Office of Research
Clinical Trials

Leading the Future of Clinical Medicine
The College of Medicine is a hub for groundbreaking clinical research. With over 30 specialized research units, our teams are dedicated to translating laboratory discoveries into life-saving clinical applications. From neurology to oncology, we provide the infrastructure and expertise necessary to push the boundaries of modern medicine.

Browse our Research Units below to view current study listings.

Clinical Trials Search

Sara Medek, MD

Sara Medek, MD

Head and Neck Cancer

Phase 3

Investigating NBTXR3 and Radiation for Head and Neck Cancer

This study is testing a treatment called NBTXR3 to see how well it works when combined with radiation therapy, compared to just using radiation therapy with or without a drug called cetuximab. The research is focused on elderly patients who have advanced head and neck squamous cell cancer but cannot undergo platinum-based chemotherapy. Participants will be randomly assigned to two groups; one will receive NBTXR3 with radiation therapy, and the other will receive radiation therapy alone or with cetuximab as chosen by their doctor. The goal is to track how long patients live without their cancer getting worse and overall survival, among other measures. The treatment happens over 7 weeks, with a series of follow-up visits planned afterward.

This study may be appropriate for those with: Metastatic Cancer

Rekha Chaudhary, MD

Rekha Chaudhary, MD

Skin Cancer & Sarcoma

Phase 2

Amivantamab Versus Cetuximab in cSCC

This study is testing a new treatment approach for people with cutaneous squamous cell skin cancer that has come back or spread and who have weakened immune systems. Participants are placed into one of two groups. One group gets amivantamab given under the skin together with hyaluronidase to help the drug stay in the body longer. The other group gets cetuximab given into a vein. Treatment is given in 28-day cycles for up to about 24 cycles unless the cancer gets worse or side effects are too severe. Doctors will check safety, how well the cancer responds, and how long people live without cancer growth. Blood tests and scans will be done throughout treatment, and some patients will be followed afterward for years. The study also collects samples for future research.

This study may be appropriate for those with: Metastatic Cancer

University of Cincinnati Cancer Center

Just In Time

Phase NA

Contact UCCC CTO for Study Activation

Specific study details/protocols can be provided upon request

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

HNSCC Longitudinal Multiomic Study

This is a non‑interventional, forward‑looking study that will collect blood and tumor tissue from adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma who are starting first‑line anti‑PD‑1 or anti‑PD‑L1 therapy as part of usual care. Samples will be tested using next‑generation sequencing (NGS), circulating tumor DNA (ctDNA) assays, RNA and immune profiling, and other multiomic techniques. Collections occur at baseline and at multiple time points during treatment and follow up. The goal is to find biomarkers that help predict who will benefit from treatment, understand how cancers become resistant, and link biomarker changes to real‑world outcomes like survival and time to next treatment. Participants are followed for up to five years; no experimental treatments are provided as part of the study.

This study may be appropriate for those with: Metastatic Cancer

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

Phase 3

Amivantamab added to carboplatin and pembrolizumab vs standard platinum regimens in treatment‑naive R/M HNSCC

This study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) are already used together to treat recurrent/metastatic head and neck squamous cell carcinoma.

This study may be appropriate for those with: Metastatic Cancer

Kerri McGovern, MD

Kerri McGovern, MD

Lung Cancer

Phase 3

Testing a New Combination Therapy for Advanced Lung Cancer

This study is looking at a new treatment combination for people with advanced lung cancer who have stopped responding to typical immune checkpoint inhibitors. The new combination includes the drugs N-803, tislelizumab, and docetaxel vs. just docetaxel alone, to see which is more effective in extending patients' lives. Adults 18 or older with this specific type of cancer could participate if they meet certain health requirements. Key aspects include the ability to follow the study procedures, managing contraception requirements, and having a specific level of health for various bodily functions. Some individuals will not qualify if they have recent treatments that conflict with the new drugs, have severe allergies to study drugs, or other significant health concerns.

This study may be appropriate for those with: Metastatic Cancer

Kyle Wang, MD

Kyle Wang, MD

Radiation Oncology

Heart Health Screening During Cancer Care

The study looks at CT scans already done for radiation planning to see if there are signs of heart disease. Adults receiving curative radiation may join. Participation involves surveys and sharing scan findings with doctors. This may help find heart disease earlier.

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Lung Cancer

Phase 3

Study of Rilvegostomig vs. Pembrolizumab with Chemotherapy for Lung Cancer

This study is testing two treatments for people with a specific type of lung cancer called metastatic squamous non-small cell lung cancer (NSCLC). It's for patients whose tumors test positive for a marker called PD-L1. The main goal is to see if a new drug, rilvegostomig, combined with chemotherapy, helps people live longer or stop their cancer from progressing more than the standard treatment, pembrolizumab, combined with chemotherapy. Patients will be randomly placed into either treatment group and both will be blind to which they are receiving to ensure fair results. The study will check how well the treatments work over approximately five years, looking specifically at survival rates and the control over cancer growth and spread. Safety and side effects are also being monitored.

This study may be appropriate for those with: Metastatic Cancer

Ian Paquette, MD

Ian Paquette, MD

Gastrointestinal Cancer

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

This study aims to determine whether rectal cancer's response to treatment is the same when patients receive chemotherapy alone before limited surgery versus when they receive both chemotherapy and radiation therapy before limited surgery, and if omitting radiation therapy improves quality of life.

This study may be appropriate for those with: Newly Diagnosed Cancer

Zulfa Omer, MD

Zulfa Omer, MD

Other

Comparing Effectiveness of Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma

This phase II study evaluates the effectiveness of mosunetuzumab versus rituximab, the standard treatment, in extending survival for patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Both mosunetuzumab and rituximab are monoclonal antibodies targeting the CD20 protein on B cells and certain cancer cells, potentially enhancing the immune system's ability to destroy cancer cells. The trial aims to determine if mosunetuzumab offers a superior survival benefit compared to rituximab for individuals with NLPHL.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor

Phase 1

Dose Escalation/​Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 alone or with Pembrolizumab

This clinical trial is assessing a new treatment, called TEV-56278, which is being tested alone and in combination with another drug called Pembrolizumab. This trial focuses on individuals who have advanced solid tumors. These types of tumors might be resistant to standard treatments or have not responded well to them. This study, conducted by Teva Branded Pharmaceutical Products, aims to find a safe and effective dosage of TEV-56278. It hopes to determine whether it can effectively inhibit tumor growth when used on its own or together with Pembrolizumab. Participants will be observed for any side effects and to see how well the tumor responds to the treatment. The study duration includes being treated for up to one year and followed for up to another year, totaling a possible two years per participant. The trial is ongoing, offering treatment possibilities for those who meet specific inclusion criteria, including having previously received treatment for their tumor and having a life expectancy of at least 12 weeks.

This study may be appropriate for those with: Metastatic Cancer

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

Phase 3

Radiation With Cetuximab or Chemotherapy

This phase 3 trial compares two treatments given with high-precision radiation therapy (IMRT) for people with advanced head and neck cancer who cannot take cisplatin. Patients are randomly placed into one of two groups. One group gets weekly cetuximab (a drug that targets the EGFR protein on some cancer cells) together with 35 daily radiation treatments over about 7 weeks. The other group gets weekly carboplatin and paclitaxel chemotherapy together with the same radiation schedule. Patients have scans and blood tests during the study and are followed after treatment at 30 days, then at 4, 6, 12, 18, 24, 30, and 36 months and then yearly. The main goal is to compare progression-free survival between the two groups. Secondary goals include comparing overall survival, side effects, where the cancer returns if it does, and changes in eating and speaking function.

This study may be appropriate for those with: Metastatic Cancer

Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 3

Beat AML Biomarker Treatment Trial

This study is a master protocol that screens people with acute myeloid leukemia (AML) using rapid lab and genomic testing. Based on the test results, each person is placed into one of several smaller treatment studies that test targeted, investigational therapies or drug combinations. The goal is to complete testing and assign patients to a matched treatment within 7 days, and then follow treatment responses and safety over time. The trial includes groups for newly diagnosed patients, relapsed or refractory patients, and a marker-negative group for those who don't match a specific marker. Some sub-studies focus on older adults or patients who cannot or choose not to get intensive chemotherapy. Follow-up can continue for years to track responses and changes in disease over time.

This study may be appropriate for those with: Newly Diagnosed Cancer

Bailey Nelson

Bailey Nelson

Genitourinary Cancer

Phase 2

Bladder Preservation Immunoradiation

This Phase II study tests whether combining the immune drug pembrolizumab with radiation therapy can allow people with muscle invasive bladder cancer to keep their bladder after the tumor has already shrunk from pre-surgery chemotherapy. Eligible patients have an excellent clinical response after neoadjuvant chemotherapy and will receive daily photon radiation to the bladder Monday through Friday for up to about 4 weeks while also getting pembrolizumab through an IV every 3 weeks. Before joining, patients have had a TURBT (a bladder tumor biopsy/removal procedure) and staging scans. The study tracks how long patients keep their bladder without cancer returning, whether they later need bladder removal (salvage cystectomy), survival outcomes, side effects, and patient-reported symptoms. Blood, urine, and tissue samples will be stored for future research. After finishing treatment, participants are followed regularly for up to 5 years.

This study may be appropriate for those with: Newly Diagnosed Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Skin Cancer & Sarcoma | Breast Cancer

Phase 1

AMXT1501 and DFMO With Standard Care

This open-label Phase 1b/2 study tests two oral drugs, AMXT 1501 and DFMO, given together with standard treatments in people with advanced ER+ / HER2- breast cancer or with unresectable or metastatic cutaneous melanoma. AMXT 1501 blocks tumor uptake of polyamines and DFMO lowers polyamine production; together they aim to reduce tumor-supporting molecules and possibly improve responses to standard therapy. In the breast cancer group the combo is given with fulvestrant and capivasertib. In the melanoma group the combo is given with pembrolizumab. The Phase 1b part uses a small dose-escalation plan to find a safe dose for Phase 2. The Phase 2 part will look for signs the treatment controls or shrinks tumors using standard tumor response rules. The study also checks drug levels in blood, changes in tumor tissue and immune genes, and overall safety. About 92 patients may be enrolled across the two groups. Participants will have screening tests, regular clinic visits each treatment cycle (28 days), imaging to measure response, and follow-up visits.

This study may be appropriate for those with: Metastatic Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma | Lung Cancer

Phase 1

Study on IOV-4001 for Advanced Melanoma and NSCLC

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

This study may be appropriate for those with: Metastatic Cancer

Robert Franklin, MD

Robert Franklin, MD

Genitourinary Cancer

Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with metastatic kidney cancer. Patients will receive 1 of the following 4 treatment options: Nivolumab 240 mg IV 1 q 2 weeks, Nivolumab 480 mg IV 1 q 4 weeks, Pembrolizumab 200 mg IV 1 q 3 weeks and Axitinib 5 mg oral Daily BID, OR Avelumab 10 mg/kg IV 1 q 2 weeks and Axitinib 5 mg oral Daily BID. Those in Arm 2 will also undergo a radical or partial nephrectomy. Efficacy will be measured by determining Overall Survival.

This study may be appropriate for those with: Newly Diagnosed Cancer

Jordan Kharofa, MD

Jordan Kharofa, MD

Gastrointestinal Cancer

Phase 3

Higher Dose Radiation Therapy for Advanced Pancreatic Cancer Trial

This study is exploring if giving higher doses of radiation can help people with advanced pancreatic cancer live longer. Participants must have already undergone 4-6 months of chemotherapy and have stable disease without progression. There are two groups in the study. One group will receive standard treatment, which could include continuing chemotherapy, a normal dose of radiation, or observation. The other group will receive higher doses of radiation over a shorter period to see if it prolongs their survival. Patients will have regular follow-ups and will be checked through blood tests, imaging scans, and tissue biopsies. They are monitored over a period that includes every three-month checkups for two years and then yearly for another three years. This study aims to not only see if survival improves but examine side effects, quality of life, and any changes in disease progression.

This study may be appropriate for those with: Metastatic Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Phase 1 - Solid Tumor | Gastrointestinal Cancer

Phase 1

Testing Abemaciclib with 5-Fluorouracil for Metastatic Colorectal Cancer

This clinical trial is investigating how well two drugs, Abemaciclib and 5-Fluorouracil (5-FU), work together in treating people with colorectal cancer that has spread to other parts of the body and hasn't responded to other treatments. The study aims to discover the safest dose of the drug combination that patients can handle without severe side effects. Participants will take Abemaciclib by mouth twice daily, and receive 5-FU through a vein on specific days during each 28-day cycle. Throughout the study, various samples will be collected to track the effectiveness and side effects of the treatment. After finishing the treatment cycles, participants will be monitored every three months for follow-up. Researchers hope this combination will provide a new option for those with this difficult-to-treat cancer type.

This study may be appropriate for those with: Metastatic Cancer

Emily Curran, MD

Emily Curran, MD

AML/ALL

Inotuzumab With Chemotherapy for Young Adults with Newly Diagnosed B-Cell ALL

This trial tests whether adding the antibody drug inotuzumab ozogamicin to a pediatric-style chemotherapy plan helps young adults (about ages 18-39) with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL). All patients first get a standard induction course of chemo. Those who respond are randomly assigned to either continue the standard multi-course chemotherapy plan or get the same chemotherapy plus inotuzumab given on days 1, 8, and 15 of a 28-day cycle (up to two cycles). The main goals are to confirm the added drug is tolerable and to see if it improves the time patients stay free of relapse or death (event-free survival). The study also looks at overall survival, disease-free survival, how much disease is left after treatment, genetic markers, drug side effects, drug levels, and how well patients take their oral medicines. Treatment can continue for months to years depending on the course, and patients are followed closely for many years after finishing treatment.

This study may be appropriate for those with: Newly Diagnosed Cancer

Tahir Latif, MD

Tahir Latif, MD

Lymphoma

Phase 2

Testing New Treatment for Residual Cancer in B-cell Lymphoma Patients

This study is testing if a new experimental treatment named cemacabtagene ansegedleucel (or cema-cel for short) can help adults with large B-cell lymphoma, a type of blood cancer. Patients who have already finished one round of regular treatment and are still showing signs of leftover cancer according to a special test are being looked at. The study compares cema-cel treatment versus just watching the patients to see which helps more in preventing cancer events and eliminating leftover cancer cells. Participants must have completed standard initial therapy, be over 18, and meet certain health criteria. Those with recent other cancers or serious current infections, among other things, cannot join. The study will check for various outcomes over several months to see how well cema-cel works and note any side effects.

This study may be appropriate for those with: Newly Diagnosed Cancer

Amanda Jackson, MD

Amanda Jackson, MD

Gynecologic Cancer

Phase 3

Trastuzumab Deruxtecan Endometrial Study

This global Phase 3 study is testing whether a targeted treatment called trastuzumab deruxtecan (T-DXd) given after surgery can help people with HER2-positive endometrial cancer live longer without the cancer returning. Participants who have newly diagnosed Stage IIC or Stage III endometrial cancer and whose tumors show HER2 will be randomly placed into one of two groups: T-DXd or standard chemotherapy (with or without radiotherapy as decided by the treating doctor). The main goal is to compare the time until cancer returns or the person dies. Doctors will also track overall survival and side effects. T-DXd is a drug that seeks out cancer cells carrying the HER2 protein and delivers a chemotherapy payload directly to them. The study is open-label, which means doctors and patients will know which treatment is given. People will be followed for several years to monitor benefit and safety, including watching for lung inflammation and heart problems, which can be serious with these kinds of treatments.

This study may be appropriate for those with: Newly Diagnosed Cancer

Jordan Kharofa, MD

Jordan Kharofa, MD

Head and Neck Cancer

Phase 1

Phase I/​ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Head and Neck Cancer

This study tests a short course of radiation (either standard X-ray photon radiation or proton radiation) given before surgery together with the immunotherapy drug pembrolizumab for people with recurrent head and neck squamous cell carcinoma. Phase I will enroll small groups to find a safe radiation dose and make sure combining the treatments before surgery is tolerable. Phase II will randomly assign patients to receive either proton or photon radiation plus pembrolizumab before salvage surgery and compare the rate of major pathologic response (very low remaining tumor on the removed tissue) to historical results. About 40 patients will be screened and randomized. Key goals are safety, whether the combination increases major pathologic response, and longer-term outcomes like disease-free and overall survival. The study includes tissue and immune testing to learn how the treatments affect the tumor and microenvironment.

This study may be appropriate for those with: Recurrent Cancer

Sara Medek, MD

Sara Medek, MD

Head and Neck Cancer

Phase 2

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA SCC of the Head and Neck

This is a phase II study evaluating the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin. Participants in Arm A will undergo IMRT 5 days a week for 6 weeks, and those in Arm B will receive the same RT plus weekly Cisplatin via IV.

This study may be appropriate for those with: Newly Diagnosed Cancer

Robert Franklin, MD

Robert Franklin, MD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma | Lung Cancer | Genitourinary Cancer

Phase 1

A Study of DB-1311 in Advanced/​Metastatic Solid Tumors

This Phase 1/2a trial aims to assess the safety and tolerability of DB-1311 in patients with advanced solid tumors through dose-escalation and dose-expansion studies.

This study may be appropriate for those with: Metastatic Cancer

Zulfa Omer, MD

Zulfa Omer, MD

Other

Testing Venetoclax for Relapsed Hairy Cell Leukemia

This study is investigating the effectiveness of the drug venetoclax in patients whose hairy cell leukemia has returned after initial treatment. Venetoclax works by blocking a protein necessary for cancer cell survival, potentially reducing cancer growth. Participants will take venetoclax daily in cycles, and their response will be monitored through medical tests, including blood samples and imaging scans. The study aims to measure the overall response rate, complete remission, and any side effects. Eligible participants are those who have not had prior venetoclax treatment and meet specific health criteria. People with certain conditions or allergies should not participate. The study will follow participants for 30 days after their last medication dose to assess outcomes.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor

Phase 2

DB 1311 Combination Trial

This is an open-label Phase 2 study testing DB-1311 given with either BNT327 or DB-1305 in people with advanced or metastatic solid tumors that have not responded to prior treatments. The study aims to check safety, side effects, how the body processes the drugs, and early signs of benefit like tumor shrinkage and longer time without disease growth. Eligible participants have one of several cancer types (liver cancer, cervical cancer, melanoma, head and neck cancer, platinum-resistant ovarian cancer, or non-small cell lung cancer) and meet basic health and lab criteria. People who previously received certain similar antibody-drug treatments, have serious uncontrolled illnesses, active brain metastases, autoimmune disease, or unresolved severe side effects are not allowed. Participants will receive study drugs in repeated treatment cycles and be seen regularly for safety checks, scans, and blood tests. The study may follow participants for up to about 6 years to collect long-term safety and outcome data.

This study may be appropriate for those with: Metastatic Cancer

Lalanthica Yogendran, MD

Lalanthica Yogendran, MD

Brain Cancer

Phase 2

New Treatments for Recurrent Glioblastoma

This clinical trial studies new drug combinations for treating people with recurrent glioblastoma, a type of brain cancer that has returned. The trial is testing whether the combination of two monoclonal antibodies, relatlimab and nivolumab, can be as effective or more effective than the current standard treatment, lomustine. These drugs work by potentially interfering with the ability of tumor cells to grow and spread. Participants will be randomly assigned to receive either the experimental drug combination or the standard chemotherapy drug. They will undergo regular checks, including MRI scans and biopsies, to track their response to treatment. The study will compare survival times and patient health outcomes between the two treatment groups over various periods up to 5 years to understand the effectiveness and safety of these treatments.

This study may be appropriate for those with: Recurrent Cancer

Lalanthica Yogendran, MD

Lalanthica Yogendran, MD

Brain Cancer

Phase 3

Vorasidenib with Temozolomide Trial

This Phase 3 clinical trial tests whether adding vorasidenib to the usual post‑radiation chemotherapy (temozolomide) helps people with newly diagnosed IDH‑mutant grade 3 astrocytoma. Patients are randomly assigned to one of two groups: both get standard radiation followed by temozolomide tablets, and one group also gets vorasidenib tablets while the other gets a placebo. Treatment cycles are 28 days, with the study drug taken daily and temozolomide given on days 1-5 of each cycle, for up to 12 months if the disease does not get worse and side effects are acceptable. Doctors will check tumor status with regular MRI scans and blood tests. The main goal is to see whether adding vorasidenib delays tumor growth (progression‑free survival). The study also looks at safety, overall survival, tumor response, time to next treatment, seizure control, and quality of life. After finishing study drugs, participants are followed for several years to monitor long‑term outcomes.

This study may be appropriate for those with: Newly Diagnosed Cancer

Sarah Sittenfeld

Sarah Sittenfeld

Gynecologic Cancer

Early Pelvic Floor Therapy Study

This is a small single group study of 28 women with invasive cervical cancer who will get pelvic external beam radiation as part of their treatment. About four weeks after finishing radiation, participants will begin pelvic floor physical therapy. The study will measure how many women have fecal incontinence three months after radiation using a standard patient survey (EORTC QLQ CX24). A survey score of 1 or higher will count as incontinence. The study will also look at urinary incontinence, sexual symptoms, overall quality of life, how well participants follow recommended dilator use, and changes in pelvic floor muscle function (measured with the Brink scale). Assessments will be done before therapy and at three months after radiation. The goal is to see how common bowel leakage is after pelvic radiation and whether early pelvic floor therapy can be studied further as a supportive care approach.

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Gastrointestinal Cancer

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.

This study may be appropriate for those with: Newly Diagnosed Cancer

Thomas Herzog, MD

Thomas Herzog, MD

Gynecologic Cancer

Phase 3

Study on New Treatment for Recurrent Ovarian Cancer

This study is looking at how effective and safe a new drug called sacituzumab tirumotecan, alone or with another drug called bevacizumab, is compared to the usual treatments for people whose ovarian cancer has come back after responding well to platinum-based chemotherapy. The study hopes to find out if patients can live longer without their cancer getting worse with this new treatment and if it's tolerable and safe. They will measure how patients respond to the treatment and monitor any side effects. The trial is in its third phase and will take place over four years.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Amanda Jackson, MD

Amanda Jackson, MD

Gynecologic Cancer

Phase 2

Study of Sapanisertib and Serabelisib with Paclitaxel for Endometrial Cancer

This clinical trial aims to test a new treatment combining sapanisertib, serabelisib, and paclitaxel for patients with advanced or recurrent endometrial cancer. This study specifically looks at participants who have undergone previous cancer treatments, such as platinum-based chemotherapy and immune checkpoint inhibitors, without success. The treatment is intended for patients who cannot be helped with surgery or radiation. To join, participants need to show specific genetic alterations related to cancer growth. The trial will measure how well the cancer responds to treatment using these medications and will check for any side effects. It's open to women who are postmenopausal or agree to use contraceptives. Participants will be monitored over several years to assess how their cancer progresses and their overall survival. However, those with other recent cancers or certain medical conditions affecting drug absorption or interaction are not eligible.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Anthony Faiola, PhD

Anthony Faiola, PhD

Brain Cancer

Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors

You will either be assigned to a group that uses the virtual reality training system or a group that will complete paper word search puzzles. At the start of the study all participants will be asked to complete three short cognitive tests to check your current memory and thinking skills. You will take the same tests again at the end of the study to see if anything has changed or improved. You will receive a schedule based on your start and end dates that explains which days you will need to complete the study-related tasks. You will complete the tasks at home for 4 weeks, 6 days a week. It will start at 15 minutes a day in week one and increase by 5 minutes each week, ending at 30 minutes a day in week four. You will receive either a VR headset and hand controllers for use with VR-CRT (and portable WI-FI hotspot if you do not have WI-FI at home) or a notebook for use with paper word-search puzzles (WSP). The research study will provide the technology to you free of charge, but with a technology sign-out consent to confirm your agreement to return the VR and WI-FI equipment once the study is completed. If you are in the VR group, you will be trained on how to use the equipment and how to connect the VR equipment to WIFI. Off-the-shelf VR equipment (Meta Quest 3/128 GB with WIFI) will be used.

Tahir Latif, MD

Tahir Latif, MD

Lymphoma

Phase 2

Testing a New Combo Therapy for Relapsed Aggressive B-cell Lymphoma

This trial studies how well a combination of drugs called ViPOR works for patients with a type of aggressive lymphoma that has returned after treatment or not responded to previous treatments. ViPOR combines 5 drugs: venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid. Each has its own function, but together they aim to stop cancer cells from growing by targeting specific proteins and supporting the immune system's ability to attack these cancer cells. This research will see whether this drug mix can help the patient's lymphoma disappear fully and track patients' survival over time. Participants will receive these medicines in cycles every 21 days for up to 6 cycles and might have tests like blood tests and scans along the way. The study checks if this treatment stops the lymphoma from growing and how safe it is.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Alberto Martini, MD

Alberto Martini, MD

Urology | Genitourinary Cancer

Phase 3

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer

This clinical trial examines the effectiveness and safety of a new drug, UGN-104, for patients with low-grade upper tract urothelial cancer. During the study, UGN-104 is administered directly into the upper urinary tract once a week for six weeks. Patients who show no signs of cancer after these treatments will have follow-up visits and may continue receiving monthly doses as a maintenance treatment plan for up to one year. These maintenance visits help ensure that the cancer does not return. The study involves regular check-ups every three months and lasts up to 15 months. Participants must have been diagnosed with this type of cancer and should not have received certain other treatments or have specific health conditions.

This study may be appropriate for those with: Recurrent Cancer

Alberto Martini, MD

Alberto Martini, MD

Urology | Genitourinary Cancer

Phase 2

Cretostimogene in High Risk NMIBC

This Phase 2 study tests a virus based drug called cretostimogene grenadenorepvec given directly into the bladder to treat high risk non muscle invasive bladder cancer. The study has several groups: patients who never had BCG vaccine treatment, those who previously had BCG, and a group that is BCG unresponsive or exposed. Some patients are randomly assigned to different ways of putting the drug into the bladder, and one group will get the drug with the chemotherapy drug gemcitabine either at the same time or one after the other. Treatment starts with a weekly induction for 6 weeks. If needed, a reinduction is given at 3 months. If high grade cancer is gone, maintenance treatments follow: three weekly treatments every 3 months in year 1, then every 6 months in year 2, with an optional extension into year 3. Doctors check disease with urine tests and bladder exams every 3 months for 2 years, then every 6 months for up to 4 years total or until the cancer returns. The study looks at response rates, how long patients stay free of high grade events, and safety.

This study may be appropriate for those with: Metastatic Cancer

Chad Zender, MD

Head and Neck Cancer

Phase 2

Cemiplimab CDX-1140 Before Surgery

This is a randomized phase 2 study for adults with stage III or IV head and neck squamous cell cancer who are scheduled for surgery. Patients are placed into one of two groups. One group receives cemiplimab (an anti PD‑1 immunotherapy) before surgery. The other group receives one dose of the anti‑CD40 drug CDX‑1140 followed a few days later by cemiplimab before surgery. Surgery is planned about 4 to 5 weeks after treatment. After surgery patients receive standard care as needed and are followed for up to two years. The main goal is to compare how often the removed tumor shows a major pathologic response (very little viable cancer left) between the two groups. The study also checks safety and side effects, looks at tumor and blood markers (including gene expression and circulating tumor DNA), studies immune changes in the tumor, and measures drug levels. Visits include screening tests, treatment infusions, the surgery visit, and follow up visits at about weeks 9–10 and 18, at 6 months, and then every 3–6 months for two years.

This study may be appropriate for those with: Metastatic Cancer

Ed Faber, MD

Ed Faber, MD

Myeloma

Phase 3

Study on Teclistamab and Talquetamab for Treating Multiple Myeloma

This study is testing two new treatment combinations for people with newly diagnosed multiple myeloma who can't have a stem cell transplant right away. It explores if mixing new drugs, teclistamab and talquetamab, with daratumumab and lenalidomide works better than the usual treatment that includes daratumumab, lenalidomide, and dexamethasone. The main goal is to see how long participants live without their disease getting worse. Researchers will also monitor how many people have no signs of cancer after a year. People who join this study should not have been treated for multiple myeloma before (except for some steroids) and must meet health criteria like not planning pregnancies. It excludes people with recent severe health issues or allergies to the drugs used. The study could last up to nine years for each participant.

This study may be appropriate for those with: Newly Diagnosed Cancer

Robert Franklin, MD

Robert Franklin, MD

Genitourinary Cancer

Phase 3

Blood Test for ctDNA in Guiding Immunotherapy After Bladder Cancer Surgery

This study investigates whether a blood test can detect leftover cancer after bladder surgery and guide further treatment using immunotherapy. It aims to identify patients who might need additional treatment to prevent cancer from coming back. The study uses blood tests to look for circulating tumor DNA (ctDNA), which can indicate cancer presence. Patients testing positive for ctDNA might receive immunotherapy drugs nivolumab and relatlimab, while those who test negative might not get additional treatment immediately. This research hopes to improve survival rates and quality of life for bladder cancer patients by tailoring immunotherapy based on ctDNA results.

This study may be appropriate for those with: Newly Diagnosed Cancer

Robert Franklin, MD

Robert Franklin, MD

Phase 1 - Solid Tumor

Phase 1

Study of JZP898 for Advanced/Metastatic Solid Tumors

This clinical research study is focused on understanding how a new drug called JZP898 works in adults who have advanced or metastatic solid tumors. The study is taking place in two parts. In the first part, researchers are exploring how the drug works on its own and when combined with another drug, pembrolizumab. They aim to find a safe dosage and look for any potential side effects. In the second part, they will further explore the effects of the combination of these two drugs on different types of tumors. The researchers want to know if these treatments can shrink the tumors and are safe for people to use over a long time. They will keep track of how the participants react to the treatment and measure things like how long the drug stays in their system and if it has any unwanted effects. People who want to participate must meet certain conditions, like having a specific kind of tumor and being able to care for themselves daily without too much help. This study is supported by Jazz Pharmaceuticals.

This study may be appropriate for those with: Metastatic Cancer

Ed Faber, MD

Ed Faber, MD

Myeloma

Phase 1

Study on ABBV-383 for Relapsed or Refractory Multiple Myeloma

This study focuses on testing the safety and dose optimization of a new drug, ABBV-383, for adults with relapsed or refractory multiple myeloma, a type of blood cancer. Researchers are trying to find the best way to use this drug by looking at different dose levels. They will monitor participants for adverse effects like cytokine release syndrome, which can cause symptoms like fever and low blood pressure. The study includes three groups, each with different dosing plans. Around 180 participants will be treated with ABBV-383 as an IV infusion every 28 days for about three years. Throughout the study, participants will undergo medical checks and fill out questionnaires to track their health and any side effects.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Kerri McGovern, MD

Kerri McGovern, MD

Breast Cancer

Monitoring in Breast Cancer- ctDNA

This study follows people with breast cancer over time to see whether tiny amounts of cancer DNA in the blood (called circulating tumor DNA or ctDNA) can show if cancer remains after treatment and predict if it will come back. Participants give blood samples at different times: during pre-surgery treatment, after surgery, during routine follow-up, and up to long-term monitoring. The study includes patients receiving pre-surgery treatment, those who have completed surgery and have no visible disease, and people who have been disease-free for five years but were originally at higher risk. Researchers will use DNA sequencing of the blood to look for signs of minimal residual disease (MRD). The main goal is to compare disease-free survival between people with and without detectable ctDNA. Secondary goals examine distant recurrence, overall survival, how MRD relates to tumor response after surgery, and how long it takes from a first positive ctDNA test to clinical recurrence. The study is observational - it only collects samples and clinical information - and aims to improve early detection of recurrence and help guide future tests and treatments.

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Head and Neck Cancer

Phase 2

Trial of BNT113 and Pembrolizumab for HPV16+ Head and Neck Cancer

This study is for patients who have a type of head and neck cancer that is linked to a virus called Human Papilloma Virus 16 (HPV16). The research is exploring whether a new treatment, using a vaccine called BNT113 together with a medicine called pembrolizumab, works better than just using pembrolizumab alone. Pembrolizumab is already a common treatment for this kind of cancer. The study is being conducted by BioNTech SE and involves patients who haven't been treated with systemic therapy for their cancer before. The first part of the study looks at safety to make sure the new combination doesn't cause serious side effects. The second part of the study compares how long patients live and how well their cancer responds to the different treatments. Those interested in participating need to have certain types of tumors that are both HPV16 positive and express a protein called PD-L1.

This study may be appropriate for those with: Metastatic Cancer

Zulfa Omer, MD

Zulfa Omer, MD

CLL

Phase 1

Study of ZE50-0134 for Chronic Lymphocytic Leukemia and Lymphomas

This clinical trial is mainly for adults who have a type of blood cancer known as Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as some other related low-grade lymphomas. The study aims to test a new treatment called ZE50-0134. It's designed to see how safe the medicine is, how it moves through the body, and how well it works against these illnesses. In the first part of the study, doctors will try different doses to find the highest amount patients can handle safely. In the second part, they will explore how effective this dose is and confirm safety with a focus on long-term usage. Patients will participate in multiple cycles of treatment, each cycle lasting four weeks, up to a total of 24 cycles, but detailed visits depend on patient grouping and specific needs. This trial is open label, meaning patients will know they are receiving ZE50-0134. Participants must be at least 18 years old and have already tried some other treatments unsuccessfully. They shouldn't have certain health issues like active infection, severe heart problems, or recent surgery. Pregnancy testing is required for women of childbearing potential before starting the drug.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor

Phase 1

Safety and Effectiveness of PYX-201 in Solid Tumors

This study is testing a new drug called PYX-201 in adults with advanced solid tumors that have not responded to usual treatments or for whom there are no suitable treatment options. The goal is to find out what dose of the drug is safe and can be tolerated well. Researchers will monitor participants to see how their bodies react to the drug, including any side effects and how the drug moves through their system. Participants must be adults with certain cancers, such as breast, lung, or ovarian cancer, who meet health criteria like having normal kidney and liver function. The study aims to explore both the safety and preliminary effectiveness of PYX-201 over approximately 3 years. It is open-label, meaning all participants receive the drug, and no placebo is involved. Measurements will focus on potential toxicities and adverse events as well as biological markers from blood samples. Participants must not have severe infections or other active cancers. The research hopes to pave the way for further clinical development if results are promising.

This study may be appropriate for those with: Recurrent Cancer

Amanda Jackson, MD

Amanda Jackson, MD

Gynecologic Cancer

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations. Participants will choose to undergo surgery to remove the fallopian tubes only and plan to have the ovaries removed in the future (BLS group) or remove the fallopian tubes and ovaries at the same time (BSO group).

This study may be appropriate for those with: Newly Diagnosed Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Phase 1 - Solid Tumor | Gastrointestinal Cancer

CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer

The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma.

This study may be appropriate for those with: Metastatic Cancer

Adam Rojan, MD

Adam Rojan, MD

Gastrointestinal Cancer

Phase 3

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

The main purpose of this study is to measure the safety and effectiveness with ivonescimab/SMT112 in combination with chemotherapy drugs, i.e., FOLFOX (Oxaliplatin, Leucovorin and Fluorouracil) in the first-line treatment of metastatic colorectal cancer (mCRC) compared to bevacizumab in combination with chemotherapy drugs, i.e., FOLFOX (Oxaliplatin, Leucovorin and 5-Fluorouracil). Ivonescimab/SMT112 is considered investigational and has not been approved by the U.S. Food & Drug Administration/local Regulatory Authority for treatment or sale. Bevacizumab is a different approved drug sold under the brand name Avastin. FOLFOX is a standard chemotherapy regimen made up of the drugs folinic acid (leucovorin, FOL), fluorouracil (5-FU, F), and oxaliplatin (Eloxatin, OX).

This study may be appropriate for those with: Metastatic Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Head and Neck Cancer

Phase 2

Study of Ficerafusp Alfa and Pembrolizumab for Head and Neck Cancer

This study focuses on patients with certain types of head and neck cancers that have come back or spread. Researchers are testing a drug called ficerafusp alfa along with pembrolizumab, comparing it to a placebo with pembrolizumab. The aim is to see if the combination is safe and works better than the placebo. The study will happen in two phases. The first phase selects the best dose of ficerafusp alfa. The second phase will see how effective the treatment is when compared to a placebo, with patients randomly assigned to receive either the active treatment or a placebo. Key goals include measuring the response rate of tumors and overall survival among participants, while watching for side effects.

This study may be appropriate for those with: Newly Diagnosed Cancer

Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 1

Beat AML Biomarker Treatment Trial

This study is a master protocol that screens people with acute myeloid leukemia (AML) using rapid lab and genomic testing. Based on the test results, each person is placed into one of several smaller treatment studies that test targeted, investigational therapies or drug combinations. The goal is to complete testing and assign patients to a matched treatment within 7 days, and then follow treatment responses and safety over time. The trial includes groups for newly diagnosed patients, relapsed or refractory patients, and a marker-negative group for those who don't match a specific marker. Some sub-studies focus on older adults or patients who cannot or choose not to get intensive chemotherapy. Follow-up can continue for years to track responses and changes in disease over time.

This study may be appropriate for those with: Newly Diagnosed Cancer

Emily Curran, MD

Emily Curran, MD

Principal Investigator

AML/ALL

Phase 1

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

This study may be appropriate for those with: Newly Diagnosed Cancer

Thomas Herzog, MD

Thomas Herzog, MD

Gynecologic Cancer

Phase 3

Sac TMT Maintenance in Ovarian Cancer

This late-stage (Phase 3) study is testing a new maintenance option for people with newly diagnosed advanced ovarian cancer whose tumors are HRD-negative. Participants will have already had surgery and first-line platinum-based chemotherapy and shown no disease growth or some response. The study compares sacituzumab tirumotecan (an antibody-drug therapy) given as maintenance, with or without the targeted drug bevacizumab, to the usual standard care (which may include observation or bevacizumab maintenance). The main goal is to find out if the study treatment keeps cancer from getting worse for longer. Researchers will also track overall survival, later disease progression after new treatments, safety and side effects, and quality of life measures using standard questionnaires. Participants will have regular clinic visits for treatment, scans, and assessments during the treatment and for long-term follow-up. The full study follow-up can last several years to measure how long benefits and side effects last.

This study may be appropriate for those with: Newly Diagnosed Cancer

Emily Curran, MD

Emily Curran, MD

AML/ALL | Blood Cancer

Adding SNDX-5613 to the Standard Chemotherapy Treatment for Newly Diagnosed Patients With Acute Myeloid Leukemia

A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination with Daunorubicin and Cytarabine in Newly Diagnosed Patients with Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype with Higher-Risk Features or MLL/KMT2A Rearranged Disease. This phase Ib trial evaluates the safety, side effects, and optimal dosage of SNDX-5613 in combination with standard chemotherapy (daunorubicin and cytarabine) for patients with newly diagnosed acute myeloid leukemia (AML) harboring NPM1 or MLL/KMT2A gene mutations. SNDX-5613 inhibits specific intracellular signaling pathways essential for the survival of cancer cells. Chemotherapy agents like daunorubicin and cytarabine work by various mechanisms to halt cancer cell proliferation, either by directly killing the cells, preventing their division, or inhibiting their spread. The hypothesis is that adding SNDX-5613 to conventional chemotherapy could potentially enhance cancer control, leading to longer periods of remission or stabilization compared to chemotherapy alone.

This study may be appropriate for those with: Newly Diagnosed Cancer

Leeya Pinder, MD, PhD

Leeya Pinder, MD, PhD

Cancer Screening & Prevention

Self Collection HPV Screening Study

This study tests whether people who collect their own vaginal sample for HPV testing get results that are as accurate as samples collected by a clinician during a pelvic exam. Adults 25 and older who were referred for colposcopy because of an abnormal cervical screening test will first collect a vaginal sample themselves, then have a clinician collect a cervical sample and undergo standard colposcopy with biopsy or other procedures if needed. Lab results are compared to see how well self-collection detects high-risk HPV and signs of cervical precancer or cancer. The study also asks participants about ease of use, comfort, and preferences for self-collection. Results will help guide use of self-collection for cervical cancer screening and possible regulatory decisions.

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Phase 1 - Solid Tumor | Gastrointestinal Cancer

ZEN003694 with Capecitabine for Advanced Solid Tumors

This phase I trial evaluates the safety, side effects, and optimal dosage of ZEN003694 combined with standard treatment capecitabine in patients with metastatic or unresectable solid tumors that have worsened after standard therapy. ZEN003694, a BET protein inhibitor, could inhibit tumor growth by targeting cells that produce excessive BET proteins. Capecitabine, an antimetabolite, converts into fluorouracil inside cancer cells to destroy them. The combination of ZEN003694 and capecitabine aims to safely treat these advanced cancers.

This study may be appropriate for those with: Metastatic Cancer

Robert Franklin, MD

Robert Franklin, MD

Genitourinary Cancer

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

This study will compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy plus definitive treatment of the primary tumor versus standard systemic therapy alone.

This study may be appropriate for those with: Newly Diagnosed Cancer

Olugbenga Olowokure, MD

Olugbenga Olowokure, MD

Gastrointestinal Cancer

Phase 3

Panitumumab for KRAS Wild Type Pancreas

This is a phase III randomized trial for adults with pancreatic ductal adenocarcinoma that cannot be removed by surgery or that has spread, whose tumors are KRAS wild type and BRAF V600E wild type by tissue testing. Participants are assigned to one of two groups. One group receives standard second line chemotherapy (one of several standard regimens) alone. The other group receives the same chemotherapy plus panitumumab, an antibody that targets EGFR on tumor cells. Treatment is given in 28 day cycles, typically with drug infusions on days 1 and 15, and continues until the cancer progresses or side effects are unacceptable. The main goal is to see whether adding panitumumab improves overall survival. The study also compares tumor response, progression free survival, side effects, and quality of life. Blood and tumor samples may be collected and stored for future research. Participants are followed for up to three years after randomization.

This study may be appropriate for those with: Metastatic Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma

Phase 1

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/​11 Mutations or PRKC Fusions

This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.

This study may be appropriate for those with: Metastatic Cancer

Kerri McGovern, MD

Kerri McGovern, MD

CML | MDS/MPN | CLL | Head and Neck Cancer | Skin Cancer & Sarcoma | Lung Cancer | Breast Cancer | Brain Cancer | AML/ALL | Lymphoma | Gynecologic Cancer | Genitourinary Cancer | Gastrointestinal Cancer | Myeloma

Phase 3

Reaching Rural Cancer Survivors Who Smoke Using Text- Based Program

Patients participating in the study will either get a text-based Scheduled Gradual Reduction (SGR) program (Project Reach) where your quit date will be 8 weeks after starting the program, or you will get the National Cancer Institute’s Clearing the Air cessation booklet where you will pick your quit date and this date will be collected. Your quit date must be within 8 weeks of receiving the Clearing the Air cessation booklet. Information on Nicotine Replacement Therapy will be provided to support cessation. You will be followed and your follow-up surveys will be collected regardless of how much you engage with the interventions provided. You will stop receiving intervention texts only if you withdraw from the study and/or text the system STOP as noted in the SGR booklet instructions. After you finish your program, your doctor will continue to follow your smoking status for 6 months.

Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 1

Testing New Drug Combo for Treating Acute Myeloid Leukemia

This clinical trial is exploring a new treatment plan for patients with newly diagnosed acute myeloid leukemia (AML). The study is testing the effectiveness and safety of combining three anti-cancer drugs: iadademstat, venetoclax, and azacitidine. These drugs work together to stop the cancer cells from growing and spreading. The main aim is to find the best dose and check if this combination approach could help improve health outcomes for these patients. Participants will first undergo an initial treatment phase, where they take these medications daily for certain periods, repeated every month for three months. If no complications arise, they continue the treatment for up to two years. The study also looks at how patients' bodies respond to the treatment over time. Participants need to be newly diagnosed, adults, in good general health, and able to swallow pills. Certain health conditions and previous treatments could disqualify someone from joining the study. During and after treatment, regular check-ups will monitor patients' responses and any side effects. This trial could point the way forward in finding a more effective treatment for AML.

This study may be appropriate for those with: Recurrent Cancer

Ed Faber, MD

Ed Faber, MD

Blood Cancer | Myeloma

Phase 1

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma (MM)

Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).

This study may be appropriate for those with: Relapsed / Refractory Cancer

Tahir Latif, MD

Tahir Latif, MD

Lymphoma | Blood Cancer

Phase 1

Study of IMPT-314 in R/​R Aggressive B-cell NHL

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL. Two cohorts of participants will be enrolled: 1) CAR T naïve and 2) CAR T experienced. Up to approximately 60 patients (15 per dose level per cohort) will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose. Phase 2 will enroll up to approximately 40 additional participants (20 per cohort) to evaluate further the safety and efficacy of IMPT-314. IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days. Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Zulfa Omer, MD

Zulfa Omer, MD

CLL

Phase 2

A Study of NX-5948 in Adults With CLL/​SLL Previously Treated

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, as long as the blood cancer is responding to the study treatment.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Ed Faber, MD

Ed Faber, MD

Myeloma

Phase 2

Study of Isatuximab, Carfilzomib, and Dexamethasone for Multiple Myeloma

This clinical study focuses on adults with relapsed or refractory multiple myeloma who have had 1 to 3 previous treatments that did not work. The study tests a combination of drugs: isatuximab, carfilzomib, and dexamethasone. The main goal is to see how well this treatment works in fighting the cancer and how the patients respond to it, both physically and emotionally. Participants go through a screening period, followed by up to a year of treatment. They will visit the study location periodically for evaluations. The study measures various outcomes, including overall response rate and possible side effects like infusion reactions. It's important that participants are able to commit to the protocol and fit specific medical criteria while avoiding recent treatments or conditions that might interfere with the study.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Zulfa Omer, MD

Zulfa Omer, MD

Lymphoma | CLL | Other

Phase 1

NX5948 in Relapsed B Cell Cancer

This is a first-in-human Phase 1 study testing NX-5948, a new oral drug that targets and destroys Bruton's Tyrosine Kinase (BTK), in adults whose B‑cell cancers came back or did not respond to prior treatment. The study has a Phase 1a dose-finding part to check safety and pick dose(s), and Phase 1b expansion parts that test the chosen dose(s) in several groups of patients with specific B‑cell cancers (for example CLL/SLL, DLBCL, MCL, FL, MZL, WM, and CNS lymphomas). The main goals are to find a safe dose, learn about side effects and how the body handles the drug, and see if the drug can shrink tumors or control disease. Patients stay on treatment until the cancer gets worse or side effects stop the drug, and they will have follow-up visits for safety and response monitoring.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Kerri McGovern, MD

Kerri McGovern, MD

Breast Cancer

Phase 3

ShortStop HER2 Duration Study

This phase 3 study tests whether people with early HER2-positive breast cancer who have no invasive cancer left after pre-surgery chemotherapy (a pathologic complete response) can safely get a shorter course of HER2-targeted therapy. Participants are randomly assigned to receive trastuzumab (with or without pertuzumab, based on their doctor's choice) for either about 6 months or about 12 months given every three weeks by IV or as a subcutaneous shot. The trial looks mainly at whether cancer recurrence-free survival with 6 months is no worse than with 12 months. It also compares patient-reported quality of life and side effects, and tracks serious side effects, overall survival, and time to brain recurrence. Patients have heart checks and routine imaging during treatment. After treatment, people are followed every 6 months for 5 years, then yearly up to 10 years total.

This study may be appropriate for those with: Newly Diagnosed Cancer

Eric Vick, MD

Phase 1 - Hematologic Malignancies

Phase 1

Study of AJ1-11095 for Untreatable Myelofibrosis Patients

This clinical trial aims to test a new drug called AJ1-11095 on patients with specific types of myelofibrosis-a serious bone marrow disorder-who have not had success with previous treatments. The study focuses on individuals who have used Type I JAK2 inhibitors but didn't benefit from them. In this early-stage research, participants will receive AJ1-11095 orally, and researchers will watch for safety concerns to figure out the best dose to use in future studies. Participants will be closely monitored for any side effects and improvements in symptoms. There will be a gradual increase in dosage until the safest, most effective dose is identified. The trial will also measure changes in symptoms like spleen size and overall health adjustments based on blood tests and other markers. The study will help identify how well the drug works in managing symptoms of myelofibrosis and its impact on patients' quality of life.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma

Phase 1

Study of GIM-531 for Advanced Solid Tumors

This study examines the safety and effectiveness of a new oral drug, GIM-531, specifically aimed at treating advanced solid tumors. It's divided into two phases, with Phase 1 focusing on finding a safe dose and Phase 2 expanding to further assess its safety and initial anti-tumor activity. GIM-531 works by selectively inhibiting certain immune cells called regulatory T-cells, which may help control tumor growth. The study measures the frequency and intensity of side effects, dose limitations, and how well the drug works against tumors. Participants will be those whose cancer has worsened after other treatments and must meet specific health criteria.

This study may be appropriate for those with: Metastatic Cancer

Chad Zender, MD

Head and Neck Cancer | Skin Cancer & Sarcoma

Phase 3

Study of Cemiplimab and Surgery for Advanced Skin Cancer

This clinical trial is exploring whether the addition of an immunotherapy drug, cemiplimab, to the usual treatment of surgery, with or without radiation, is more effective for patients with advanced skin cancer that can be surgically removed. The trial focuses on squamous cell carcinoma that has returned or is at a stage that allows for surgery. Participants will be split into two groups: one receiving surgery alone and the other receiving cemiplimab before surgery, followed by surgery and potentially additional treatment. The researchers aim to see if the combined treatment approach leads to better outcomes such as longer event-free survival, improved disease-free survival, overall survival, and less frequent recurrence when compared to the standard treatment alone. Cemiplimab infusion is delivered through IV over 30 minutes as part of the experimental regimen.

This study may be appropriate for those with: Metastatic Cancer

Sara Medek, MD

Sara Medek, MD

Head and Neck Cancer

Phase 4

Study of Toripalimab With Chemotherapy for Nasopharyngeal Cancer

This study is looking at how well a combination of drugs, including a new one called toripalimab, works as a treatment for people with advanced nasopharyngeal cancer that has returned or spread. Nasopharyngeal cancer is a type of cancer located in the nose and throat region. The researchers will use special criteria to measure how well the tumors respond to the treatment. People in this study should not have cancer that can be treated with local therapies aimed at curing them or have a quickly progressing illness. They also shouldn't have received this kind of treatment before in a setting where cancer has come back or spread. The study hopes to see positive results, like reducing tumor size and stopping cancer from getting worse, at follow-up periods up to 42 months. Those participating will be regularly checked to see how their body is responding to the treatment.

This study may be appropriate for those with: Metastatic Cancer

University of Cincinnati Cancer Center

Just In Time

TEMPUS - JUST IN TIME (JIT) Study Listing

This is a listing of TEMPUS "Just In Time" (JIT) studies. Current study-specific protocols and activation details are not included here; investigators, interventions, eligibility, visit schedules, duration, and expected outcomes vary by protocol. For full protocol documents, inclusion/exclusion criteria, visit schedules, potential risks/side effects, and activation requirements, contact the UCCC CTO. A PDF containing the current TEMPUS TIME JIT study listing is available; specific study details can be provided on request.

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Lung Cancer

Phase 3

Study on BAY 2927088 for Lung Cancer with HER2 Mutations

This study is examining a new treatment called BAY 2927088 for people with advanced non-small cell lung cancer (NSCLC) that involves specific changes in the HER2 gene. The goal is to see how well this drug works compared to standard chemotherapy. Participants will receive either the new medication orally or standard chemotherapy via infusions. Doctors will use imaging tests like CT and MRI scans to track cancer progress, along with various health tests. The study aims to observe progression-free survival and overall survival rates, and assess safety through the observation of side effects and adverse reactions.

This study may be appropriate for those with: Metastatic Cancer

Bailey Nelson

Bailey Nelson

Gynecologic Cancer | Genitourinary Cancer | Gastrointestinal Cancer

Feasibility of an Oral 5 Strain Probiotic (PGC) for GI Toxicity Mitigation During Pelvic Radiation

The exact mechanism of GI symptoms is elusive, but there is sufficient data to suggest that the intestinal microbiome plays a role in radiation-induced GI injury. This feasibility trial will evaluate whether an oral 5 strain probiotic (PGC) can be safely and effectively administered during pelvic RT. PGC will be supplied by Pendulum Therapeutics. Pendulum has completed trials using PGC in non-cancer conditions. The investigators hypothesize that oral supplementation with PGC for GI toxicity mitigation during pelvic radiation is feasible. The intervention will be considered feasible if probiotic tolerability and patient adherence are appropriate. An overall probiotic adherence rate of ≥ 80% by ≥ 70% of patients will be considered acceptable. If feasible, these results will support evaluation of toxicity mitigation in randomized subsequent Phase II/III trials of PGC supplementation during pelvic radiation.

This study may be appropriate for those with: Metastatic Cancer

Jordan Kharofa, MD

Jordan Kharofa, MD

Gastrointestinal Cancer

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

This is a randomized trial for patients diagnosed with Esophageal Cancer comparing Proton Beam Therapy and Intensity Modified Photon Radiotherapy. Patients randomized to Arm 1 will undergo Proton Beam therapy with concurrent weekly chemo with paclitaxel/carboplatin. Patients in Arm 2 will undergo IMRT with concurrent paclitaxel/carboplatin. The primary endpoint of this study is Overall Survival.

This study may be appropriate for those with: Newly Diagnosed Cancer

Timothy Struve, MD

Timothy Struve, MD

Genitourinary Cancer

Phase 2

Testing Radiation Plus Immunotherapy for Metastatic Renal Cell Cancer

This clinical trial is testing whether adding a special type of radiation therapy called stereotactic ablative radiation therapy (SABR) to the usual treatment of immunotherapy can help patients with renal cell cancer that is metastatic, meaning it has spread to other parts, or cannot be surgically removed. Patients are divided into two groups. One group receives only immunotherapy, while the other group gets both SABR and immunotherapy. The hope is that using both SABR and immunotherapy could shrink tumors or stop them from growing. By doing this, doctors aim to see if fewer surgeries are needed and if the time without cancer worsening can be extended. The study will also look at safety and possible side effects such as immune system reactions.

This study may be appropriate for those with: Metastatic Cancer

Zulfa Omer, MD

Zulfa Omer, MD

Lymphoma | CLL

Phase 1

Study on UB-VV111 and Rapamycin for CD19+ B-cell Malignancies

This Phase 1 research involves the new drug UB-VV111, tested with or without another drug called Rapamycin, in people with specific B-cell cancers that have returned or don't respond to existing treatments. The goal is to understand if these treatments are safe and how well they work against cancer. Participants need to meet certain criteria, such as being 18 years or older, having specific types of relapsed or refractory B-cell lymphomas or leukemia, having no serious uncontrolled health conditions, and having good organ function. People can't participate if they are pregnant, have certain infections, or are part of another trial. Expected outcomes are monitored over a two-year timeframe.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Thomas Herzog, MD

Thomas Herzog, MD

Gynecologic Cancer

Phase 3

Rina S Versus Standard Chemotherapy

This is a global Phase 3 study that will enroll about 544 people with recurrent or progressive endometrial cancer after prior therapy. Participants are randomly assigned 50:50 to get either the investigational drug Rinatabart Sesutecan (Rina S) or the investigator's choice of standard chemotherapy (paclitaxel or doxorubicin). Everyone receives active treatment; no one gets a placebo. The study will follow participants for up to about 3 years. The main goals are to compare how long patients live without their cancer getting worse (progression free survival) and overall survival. The study will also look at tumor response, duration of response, side effects, and quality of life. Treatment time varies by person but is expected on average to be about 4 to 6 months. Visits to the study site are required for treatment and assessments.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Phase 1 - Solid Tumor

Phase 1

Testing LY3962673 in KRAS G12D-Mutant Solid Tumors

This study is examining a new drug, LY3962673, which aims to treat certain types of advanced cancer that have a specific mutation known as KRAS G12D. These cancers include pancreatic, lung, and colorectal cancers. The study is testing how safe LY3962673 is when used alone and in combination with other chemotherapy drugs, as well as how well it works in reducing tumor size. It will last about five years, and participants will undergo various assessments to track their response to the treatment. The study hopes to determine both the best way to use the drug and its effectiveness over time. Participants who previously had treatments that didn't fully work for these specific cancers might qualify.

This study may be appropriate for those with: Metastatic Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Phase 1 - Solid Tumor

Phase 1

Safety Study of YL211 for Advanced Solid Tumors

This clinical trial tests a new drug called YL211 to see if it's safe and effective for people with advanced solid tumors that have no other treatment options. The study is in its early stages (Phase 1) and takes place at multiple centers. There are three parts: Part 1 tests different doses to find the most tolerable dose; Part 2 checks the safety and impact in more patients; and Part 3 looks at safety and effectiveness at the chosen dose. People participating will receive the medicine intravenously and continue until conditions for stopping arise. Participants should be adults with advanced solid tumors, generally healthy apart from cancer, and must not have uncontrolled illnesses or recent allergies related to similar medicines. The study will observe any side effects, how the drug moves through the body, and how well it works against the cancer over approximately three years.

This study may be appropriate for those with: Metastatic Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Gastrointestinal Cancer

Phase 2

Efficacy and Safety of Adjuvant in Patients With Resected Pancreatic Ductal Adenocarcinoma

This study is evaluating an experimental drug called autogene cevumeran in patients with pancreatic ductal adenocarcinoma that has been resected (surgically removed). The goal is to find out whether combining these newer therapies (atezolizumab and autogene cevumeran) with standard chemotherapy is safe and more effective at reducing the risk of cancer returning compared to chemotherapy alone.

This study may be appropriate for those with: Newly Diagnosed Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Phase 1 - Solid Tumor

Phase 1

Study of PF-07934040 for Advanced Tumors with KRAS Gene Mutations

This clinical study is testing a new cancer medicine called PF-07934040. The study focuses on people with advanced solid tumors, which are cancers that don't go away or stay away after treatment. These tumors have a specific genetic mutation in the KRAS gene, which can make cancer cells grow quickly. The study includes people with types of cancer such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). The study is in Phase 1, meaning it's looking at how safe the medicine is and what effects it has. Researchers also want to find the best dose to give to patients. The medicine can be taken alone or with other cancer treatments. Participants will take PF-07934040 as a pill twice a day in cycles of either 21 or 28 days. Those who are also getting other treatments will have those given by IV at the clinic. The study will last up to four years, with participants visiting the clinic 1 to 4 times every cycle. They can continue the treatment as long as it helps control their cancer. After stopping the medicine (usually around two years), they will be followed for two more years to check on their health. To join the study, participants must have a KRAS gene mutation and show that their cancer has not responded to standard treatments. They must also have a good level of daily functioning and at least one measurable tumor that has not been treated with radiation. There are also specific criteria for different cancer types, such as the number of previous treatments. People cannot join if they have certain health problems, like lung diseases that need steroids, immune system issues, or severe nerve damage. They also can't participate if they've had major surgery or radiation therapy recently, or if they have allergies to the study treatments. The study aims to learn if PF-07934040 is safe and effective in treating these advanced cancers. It will measure safety through any side effects and lab test changes. It will also look at how many participants respond to the treatment, how long it takes for the medicine to reach its peak in the body, and how long it stays there.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Ed Faber, MD

Ed Faber, MD

Myeloma

Phase 3

Teclistamab Maintenance Study

This is a Phase 3 clinical trial for people with newly diagnosed multiple myeloma who have completed initial therapy and are starting maintenance treatment after autologous stem cell transplant. Participants are randomly assigned to one of three maintenance options: teclistamab plus lenalidomide, teclistamab alone, or lenalidomide alone. The study will compare how long people live without their disease getting worse (progression-free survival) and how many achieve a deep response with no detectable disease at 12 months. Participants will be followed during treatment and for long-term outcomes, including overall survival, quality of life, and safety, for up to about 8 years. The goal is to find whether teclistamab, by itself or with lenalidomide, gives better and longer-lasting control of myeloma than standard lenalidomide alone.

This study may be appropriate for those with: Newly Diagnosed Cancer

Jordan Kharofa, MD

Jordan Kharofa, MD

Cancer Screening & Prevention

Family Genetic Communication Study

This study tests two ways of letting close family members know about inherited genetic changes found in people newly diagnosed with colorectal cancer. First, patients (called probands) get blood testing for inherited cancer genes. If a harmful inherited change is found, the patient and their eligible first-degree relatives are put into one of two groups. In the usual approach, the patient tells relatives about the test result (proband-mediated). In the other approach, a healthcare team member contacts relatives directly to offer testing and information (provider-mediated). The main goal is to see which method leads to more relatives getting genetic testing within 6 months. The study also looks at whether relatives who test positive take prevention steps within a year, whether testing differs by patient subgroups (such as age, race, or rural vs. urban), the range of inherited variants found, and patient disease-free survival over 3 years. Probands are followed up for up to 3 years; relatives are followed for up to 1 year. Materials and counseling are provided in English or Spanish.

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Gastrointestinal Cancer

Phase 1

DB 1324 in Gastrointestinal Cancer

This first-in-human study will test DB-1324 in people with advanced or metastatic gastrointestinal (GI) cancers. The study has two main phases. Phase 1 uses dose escalation and expansion steps to find a safe and tolerable dose and to learn how the drug behaves in the body. Phase 2 will further check safety and look for signs the drug can help certain GI cancers. Participants will get DB-1324 regularly until their disease worsens, they have unacceptable side effects, they choose to stop, or another reason for stopping occurs. Researchers will watch for side effects, serious adverse events, and dose-limiting toxicities to find the maximum tolerated dose and recommended doses for later studies. The study will also measure tumor response, how long any responses last, time until progression, and drug levels in the blood. Participants will need to provide tumor tissue or allow a biopsy for testing biomarkers such as CDH17.

This study may be appropriate for those with: Metastatic Cancer

Amanda Jackson, MD

Amanda Jackson, MD

Gynecologic Cancer

Phase 1

IMGN151 in Gynecologic Cancers

This Phase 1b study tests IMGN151, an investigational cancer drug, in adults with gynecologic cancers. About 377 people will join at about 50 sites. Participants are placed into treatment groups: IMGN151 given with carboplatin, with olaparib, with bevacizumab, or as IMGN151 alone. The main goals are to find dose‑limiting toxicities and to assess safety and side effects over the study period, and to look for early signs that tumors respond (shrink or stop growing). Participants must have good performance status, most need at least one measurable tumor by scan, and must meet timing rules for prior treatments. People with certain ovarian tumor types, prior FRα‑targeting therapy, large prior radiation to the marrow, or other significant medical issues are not allowed. The study lasts about 3 years overall. Participants will come for regular clinic visits for infusions, blood tests, and scans and will stay on treatment until disease progression, unacceptable side effects, or other reasons to stop.

This study may be appropriate for those with: Newly Diagnosed Cancer

Zulfa Omer, MD

Zulfa Omer, MD

CLL

Phase 2

CLL/SLL- Received 2nd G BTKi+/-Obinutuzu

In this phase II, multicenter trial, we seek to test the hypothesis that administration of up to 12 cycles of epcoritamab following a 12 months or greater time period of acalabrutinib +/- obinutuzumab or zanubrutinib +/- obinutuzumab in patients who have attained a partial response or better will have a high CR conversion rate with uMRD that enables discontinuation of therapy and lead to durable remission. Additionally, Patients attaining this exceptional uMRD CR at completion of therapy will have evidence of autologous T-cell response toward the patient pre- treatment CLL cells. A safety lead in of the combination for the first 9 patients followed by Simon's 2 stage design will be implemented. Following our inclusion and exclusion criteria, eligible patients will be treated with subcutaneous epcoritamab for a total of 12 cycles while continuing their BTKi therapy. Patients will be assessed for disease response as defined by the iw-CLL 2018 response criteria following completion of cycle 6 and 12 of epcoritamab by peripheral blood labs, CT imaging and bone marrow biopsy for morphology and flow cytometry (if labs/imaging indicating CR) and MRD status through NGS assay (ClonoSEQ). MRD will be performed from bone marrow samples if BMBx is done, and if not done peripheral blood sample will be used for MRD status. Patients with undetectable MRD will stop treatment after completing the consolidative epcoritamab treatment. If patients or their treating physician desire them to stay on BTKi, they may elect to do so. Those who have dMRD will be monitored for disease progression with consideration of starting back on BTKi monotherapy if they showed any signs of PD. All patients who complete 12 cycles of epcoritamab consolidative therapy will have the ability to continue BTKi as monotherapy regardless of MRD status, pending discussion with the patient and treating-physician.

This study may be appropriate for those with: Newly Diagnosed Cancer

Alberto Martini, MD

Alberto Martini, MD

Urology | Genitourinary Cancer

Phase 2

Study on Herpes Virus Injection for Bladder Cancer Treatment

This clinical study is testing a treatment called T3011, which is a special type of Herpes Virus injection. It's for patients who have bladder cancer that doesn't respond well to standard treatment like BCG. In this study, doctors will give the virus directly into the bladder and check if it's safe and if it helps fight cancer. They will also test which dose works best by trying two different amounts. Around 40 participants will be enrolled in the latest part of the study. The doctors hope to see good results where the cancer doesn't come back and measure how many patients respond completely to the treatment. Patients will visit clinics for check-ups and tests regularly for up to 24 months.

This study may be appropriate for those with: Recurrent Cancer

Sara Medek, MD

Sara Medek, MD

Head and Neck Cancer

Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma

The purpose of this research is to study if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treating your cancer, while reducing the side effects of radiation and improving quality of life. The current standard care treatment for OPSCC can have debilitating side effects. The researchers believe that using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of microscopic cancer might be just as effective for treating your cancer with less side effects. The combination of these approaches is not considered the current standard of care and will be considered research. You will continue to receive standard systemic therapy of cisplatin during your radiation therapy.

This study may be appropriate for those with: Newly Diagnosed Cancer

Zulfa Omer, MD

Zulfa Omer, MD

CLL

Phase 2

A Multicenter Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated and T474 Gatekeeper Mutant CLL/SLL

This is a phase II research study being conducted at multiple locations. It is designed to test the combination of obinutuzumab and LP‑168 in two groups of people with CLL/SLL: those who have been treated before, and those whose disease has a specific genetic change that makes it harder to treat with standard therapies.Participants will take LP‑168 once a day, starting on the first day of treatment, for up to 12 treatment cycles. About two weeks after finishing the first six cycles, their progress will be checked using blood tests, imaging scans, and a bone marrow sample. After this check‑in, participants will continue taking LP‑168 and will also begin receiving obinutuzumab. Obinutuzumab will be given over six cycles, starting in cycle 7, on several scheduled days early on and then once per cycle through cycle 12. Everyone will receive at least 12 cycles of treatment. At the end of cycle 12, participants will be evaluated again to see how well the treatment worked. This will include blood tests, scans if needed, and examination of blood and bone marrow samples to look for any remaining signs of disease. Participants whose disease is no longer detectable at that point may choose to stop treatment. Those who still have signs of disease will continue taking LP‑168 and will be followed every six months. Additional testing may be done later, and treatment can be stopped if no disease is detected at that time.

This study may be appropriate for those with: Recurrent Cancer

Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Lymphoma | Phase 1 - Solid Tumor | Myeloma

Phase 2

TAPUR Study: FDA Approved Drugs Targeting Tumor Gene Abnormalities

The TAPUR Study is focused on understanding how FDA-approved drugs that target specific abnormalities in tumor genes work for patients with advanced cancers. These include solid tumors, multiple myeloma, and non-Hodgkin lymphoma that have a detectable genetic feature that can potentially be treated with these medicines. The study evaluates participants' responses, safety of treatments, survival rates, and helps to form ideas for new clinical trials based on real-world usage of these therapies. Anyone aged 12 or older with certain advanced cancers whose condition can be measured and who meets other criteria may participate. However, those with certain conditions like primary brain tumors or unmeasurable disease may not be eligible.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Jamie Lewis, MD

Jamie Lewis, MD

Breast Cancer

Exploring Mindfulness Apps for Breast Cancer Survivors

This study examines two digital mindfulness programs designed to help younger women who survived breast cancer. Participants are randomized into two groups: one using a live, instructor-led program over the internet, called MAPs LO, delivered via Zoom, and the other using a self-paced app-based version, called MAPs App. The research aims to determine which approach best improves the mental health of those who completed their primary cancer treatment and now have depression symptoms. Another goal is to identify specific patient traits or psychological conditions that predict which digital format works better for whom. The study will also assess the cost-effectiveness of these different interventions, which is essential information for insurance, healthcare providers, and patients. Participants need to have completed initial treatments at least six months ago and show depressive symptoms but should not be engaged in similar ongoing trials.

This study may be appropriate for those with: Newly Diagnosed Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Lung Cancer

Phase 3

Study of MK-1084 and Pembrolizumab for Lung Cancer

This clinical study is evaluating a combination of MK-1084 and pembrolizumab as a treatment for people with a certain type of lung cancer called KRAS G12C mutant metastatic Non-small Cell Lung Cancer (NSCLC) who also have high levels of PD-L1 protein in their tumors. The study aims to find out if this combination works better than pembrolizumab with a placebo in terms of slowing down tumor growth and improving survival rates. Participants who join will be randomly assigned to get either the new treatment or the standard treatment. The study also looks at side effects and quality of life changes for participants. People with active infections, certain heart conditions, or those who have had specific types of cancer therapies recently are not eligible to participate.

This study may be appropriate for those with: Newly Diagnosed Cancer

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Lung Cancer

Phase 3

Neladalkib vs Alectinib in ALK NSCLC

This is a global Phase 3 study that will randomly assign people with ALK-positive advanced non-small cell lung cancer (who have not had prior systemic treatment for their lung cancer) to one of two first-line treatments: neladalkib (NVL-655) or alectinib. About 450 participants will be split evenly between the two drugs. The main goal is to see which drug keeps the cancer from getting worse for a longer time, using independent radiology review. Other goals include overall survival, brain (intracranial) outcomes, tumor response rates, safety and side effects, and patient-reported quality of life. Treatment continues until the cancer progresses or side effects prevent further treatment. Participants will be followed with regular scans and visits, and some measures will be collected for up to five years after the first patient is dosed.

This study may be appropriate for those with: Metastatic Cancer

Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 3

Beat AML Biomarker Treatment Trial

This study is a master protocol that screens people with acute myeloid leukemia (AML) using rapid lab and genomic testing. Based on the test results, each person is placed into one of several smaller treatment studies that test targeted, investigational therapies or drug combinations. The goal is to complete testing and assign patients to a matched treatment within 7 days, and then follow treatment responses and safety over time. The trial includes groups for newly diagnosed patients, relapsed or refractory patients, and a marker-negative group for those who don't match a specific marker. Some sub-studies focus on older adults or patients who cannot or choose not to get intensive chemotherapy. Follow-up can continue for years to track responses and changes in disease over time.

This study may be appropriate for those with: Newly Diagnosed Cancer

Alberto Martini, MD

Alberto Martini, MD

Urology | Genitourinary Cancer

Phase 3

Trial of Nadofaragene Firadenovec vs. Observation for Bladder Cancer

This study is testing a treatment called Nadofaragene Firadenovec for people with intermediate-risk non-muscle invasive bladder cancer. Participants are randomly chosen to either receive this treatment or just be observed without treatment for comparison. The main goal is to see how well the treatment works at preventing the return or worsening of cancer within two years. Researchers will also track any side effects from the treatment. To join, participants must have had certain types of bladder tumors and tumors must have been removed within the past 60 days. Those with more serious or different kinds of bladder cancers cannot join.

This study may be appropriate for those with: Metastatic Cancer

Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 2

Beat AML Biomarker Treatment Trial

This study is a master protocol that screens people with acute myeloid leukemia (AML) using rapid lab and genomic testing. Based on the test results, each person is placed into one of several smaller treatment studies that test targeted, investigational therapies or drug combinations. The goal is to complete testing and assign patients to a matched treatment within 7 days, and then follow treatment responses and safety over time. The trial includes groups for newly diagnosed patients, relapsed or refractory patients, and a marker-negative group for those who don't match a specific marker. Some sub-studies focus on older adults or patients who cannot or choose not to get intensive chemotherapy. Follow-up can continue for years to track responses and changes in disease over time.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

Phase 2

Testing Ado-Trastuzumab Emtansine Compared to the Usual Treatment for Salivary Gland Cancer

A CONTROLLED, RANDOMIZED PHASE II TRIAL OF DOCETAXEL PLUS TRASTUZUMAB VERSUS ADO-TRASTUZUMAB EMTANSINE FOR RECURRENT, METASTATIC, OR TREATMENT-NAÏVE, UNRESECTABLE HER2-POSITIVE SALIVARY GLAND CANCER

This study may be appropriate for those with: Metastatic Cancer