Office of Research
Clinical Trials

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

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.

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer

This phase III trial evaluates the effectiveness of pembrolizumab versus observation in treating patients with early-stage triple-negative breast cancer who have reached a pathologic complete response following preoperative chemotherapy combined with pembrolizumab. Pembrolizumab, a type of immunotherapy using monoclonal antibodies, aims to boost the immune system's ability to combat cancer and may block tumor cells from multiplying and spreading. The study aims to ascertain whether observation alone offers the same risk of cancer recurrence as continued pembrolizumab treatment in these patients after surgery.

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

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

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

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

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

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

Study on Heated Chemotherapy and Niraparib for Advanced Ovarian Cancer

This study is testing a new method of chemotherapy for treating advanced ovarian, primary peritoneal, and fallopian tube cancers. Researchers are comparing two groups: one receiving heated chemotherapy (HIPEC) with cisplatin during surgery and the other not receiving HIPEC. Both groups will receive additional standard chemotherapy post-surgery followed by a medication called niraparib. The study aims to see if this heated chemotherapy method helps people stay cancer-free for longer. It's targeted at patients with stage III or IV of these specific cancers who have completed standard neoadjuvant therapy and are ready for surgery. The study measures progression-free survival as its main outcome.

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

Phase 2 Study of ACR-368 in Endometrial Cancer

This Phase 2 study tests ACR-368 in people with high-grade endometrial cancer. Participants are placed into one of three groups. Arms 1 and 2 use a lab test called OncoSignature to predict sensitivity to ACR-368: Arm 1 (OncoSignature Positive) receives ACR-368 alone; Arm 2 (OncoSignature Negative) receives ACR-368 plus ultra-low dose gemcitabine (ULDG). Arm 3 (no OncoSignature testing) also receives ACR-368 with ULDG; EU sites enroll only to Arm 3. Treatment continues until the cancer gets worse, side effects become unacceptable, or the person stops. The main goal is to measure tumor response by CT or MRI every 8 weeks for up to 2 years. Safety, some drug levels in blood, overall survival, time without cancer growth, and duration of any response are also tracked. Key eligibility includes prior platinum chemotherapy and prior anti-PD-(L)1 therapy, measurable disease, and adequate overall health. Certain conditions like uncontrolled viral infections, serious heart disease, recent major surgery or recent cancer treatment, symptomatic brain metastases on high-dose steroids, bowel obstruction, or prior CHK1 inhibitor use will exclude people from joining.

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

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

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

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.

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

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

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

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

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.

Adjuvant Radiation for Pleural Mesothelioma

This randomized Phase 3 study compared two approaches for treating stage I-IIIA malignant pleural mesothelioma that is suitable for pleurectomy/decortication (P/D). All patients received surgery to remove visible tumor and standard chemotherapy (pemetrexed with cisplatin or carboplatin). Half of the patients were randomly assigned to also get adjuvant hemithoracic intensity-modulated pleural radiation therapy (IMPRINT), a targeted form of radiation to the chest lining, while the other half received no additional radiation. The main goal was to see if adding IMPRINT improves overall survival. Secondary goals included measuring local control, spread to distant sites, progression-free survival, treatment-related side effects, and quality of life. The study also planned exploratory analyses of staging accuracy, surgical outcomes, biomarkers, and radiation dose effects. After treatment, patients were followed frequently for the first 2 years and then every 6 months for up to 5 years. The trial was terminated early, so only limited outcome data were available.

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

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

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