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 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

Learn More about Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA SCC of the Head and Neck
Robert Franklin, MD

Robert Franklin, MD

Genitourinary Cancer

Phase 3

Pasritamig With Docetaxel Study

This phase 3 trial tests whether adding pasritamig to standard chemotherapy (docetaxel) helps men with metastatic castration resistant prostate cancer live longer without their disease getting worse on scans. Eligible men must have prostate adenocarcinoma that has spread, be on hormone lowering treatment or surgically castrated, have had at least one prior androgen receptor targeted therapy, and be in generally good health for cancer treatment. Participants are randomly assigned to receive pasritamig plus docetaxel or docetaxel alone. Doctors will use imaging scans to track when the cancer progresses, and will also measure overall survival, pain and quality of life, PSA blood changes, need for more treatment, bone related problems, tumor response if measurable, and side effects. Blood tests, scans, and questionnaires are used during treatment and for follow up. The main question is whether the combination delays radiographic progression compared with chemotherapy alone.

This study may be appropriate for those with: Metastatic Cancer

Learn More about Pasritamig With Docetaxel Study

Mahmoud Charif, MD

Breast Cancer

Study of CDK4/6 Inhibitor Dosing in Older Metastatic Breast Cancer Patients

This study seeks to help older patients (65 years and above) with metastatic breast cancer by testing different dosing strategies for CDK4/6 inhibitors. It aims to determine if starting these medications at a lower dose and increasing as tolerated could help patients manage side effects better, enabling them to continue their treatment longer. Participants can choose between the drugs palbociclib or ribociclib and an endocrine therapy, with dosing randomly assigned to either start at full dose (common practice) or begin at a lower dose and increase if tolerated. The trial will track the length of time patients stay on their medication, the side effects experienced, and overall survival and quality of life.

This study may be appropriate for those with: Metastatic Cancer

Learn More about Study of CDK4/6 Inhibitor Dosing in Older Metastatic Breast Cancer Patients
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

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

Learn More about Blood Test for ctDNA in Guiding Immunotherapy After Bladder Cancer Surgery
Davendra Sohal, MD, MPH

Davendra Sohal, MD, MPH

Gastrointestinal Cancer

Phase 1

DISP 10 Advanced GI Cancer Study

This is an early phase (Phase 1) study testing DISP 10, a combination of an engineered adenovirus (DV-10) and a CAR T cell therapy (idecabtagene vicleucel or ide‑cel). Adults with advanced or metastatic cancers of the esophagus, gastroesophageal junction, stomach, or colon who have measurable disease and at least one site for biopsy may join. The study has two parts: Part 1 slowly increases doses to find a recommended dose for expansion, focusing on safety and dose‑limiting toxicities. Part 2 treats more participants at that dose to learn about safety and whether tumors shrink or stabilize. Main goals are to record side effects, establish a safe dose, and measure tumor response. Participants must have good organ function and no major infections, recent transplants, or prior similar viral or CAR T therapies. Follow up includes frequent checks after treatment and ongoing monitoring for up to 2 years, with long term survival follow up possible up to 15 years.

This study may be appropriate for those with: Metastatic Cancer

Learn More about DISP 10 Advanced GI Cancer Study
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

Learn More about Testing a New Combination Therapy for Advanced Lung Cancer
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

Learn More about ZEN003694 with Capecitabine for Advanced Solid Tumors
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

Learn More about Comparing Proton Therapy to Photon Radiation Therapy for Esophageal 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

Learn More about Teclistamab Maintenance Study
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

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

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

Learn More about Study on UB-VV111 and Rapamycin for CD19+ B-cell Malignancies
Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 2

Phase II Trial of Asciminib, Prednisone, Blinatumomab, for Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia

This phase II study tests whether adding asciminib to a treatment plan of dasatinib, prednisone, and blinatumomab helps adults newly diagnosed with Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Treatment has three parts: an induction phase to try to put the leukemia into remission, a post-remission consolidation phase with repeated 42-day cycles, and a maintenance phase where patients take oral drugs for up to five years if they benefit. Doctors will check response by measuring BCR-ABL levels in blood/marrow and by flow cytometry for measurable residual disease. Main goals are to see how many people reach a major molecular remission by about day 85 and to track remission rates, survival, and side effects over time. The study also collects samples to study genetic changes linked to response or resistance.

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

Learn More about Phase II Trial of Asciminib, Prednisone, Blinatumomab, for Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia
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

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

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

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

Learn More about Safety and Effectiveness of PYX-201 in Solid Tumors
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

Learn More about Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Robert Franklin, MD

Robert Franklin, MD

Genitourinary Cancer

Phase 1

Study of JANX007 in Metastatic Castration-Resistant Prostate Cancer

This study is exploring a new treatment called JANX007 for adults with metastatic castration-resistant prostate cancer. It is a Phase 1 trial, which is the first time this drug is being tested in humans. The main goal is to check its safety and find out if it can be tolerated by patients. Scientists will also look at how the body processes the drug and its initial effectiveness in fighting cancer. Participants need to have a type of prostate cancer that didn't respond to other treatments including hormone therapy and chemotherapy. The study will not include people who have had an organ transplant or specific heart problems.

This study may be appropriate for those with: Metastatic Cancer

Learn More about Study of JANX007 in Metastatic Castration-Resistant Prostate 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

Learn More about Bladder Preservation Immunoradiation
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

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

Learn More about Study on IOV-4001 for Advanced Melanoma and NSCLC
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

Learn More about Higher Dose Radiation Therapy for Advanced Pancreatic Cancer Trial
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