Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests new drugs with pembrolizumab, an immune treatment, and chemotherapy. It checks safety, side effects, doses, and how well treatment works. It is for people with untreated, HER2-negative gland cancer of the stomach, food pipe, or where they meet that has spread or cannot be removed by surgery.
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have cancer confirmed by a tissue or cell test that has spread or cannot be removed by surgery, with no prior treatment for this advanced cancer.
- Not be expected to need surgery to remove the tumor during treatment.
- Have a tumor that tests negative for HER2, a protein that can help cancer grow.
- Provide a tissue sample from a tumor that has not had radiation treatment.
- Have cancer that can be measured on scans.
- Have organs that work well enough and be fully active or limited only in hard physical activity.
- Be expected to live at least 6 months.
- Have side effects from past cancer treatment return to mild levels or your usual health. Hormone-related side effects may be allowed if treated with hormone replacement.
Who can't join
- Have squamous cell cancer or cancer with cells that do not have a clear type, rather than gland cancer.
- Have lost more than 20% of your weight in the past 3 months.
- Have severe eye problems, moderate or worse nerve damage in the hands or feet, or a history of inflammatory bowel disease.
- Have blocked bowels, poor food intake, trouble taking pills, or poorly controlled diarrhea.
- Have a history of lung inflammation or scarring, current or suspected lung disease of this type, or an active infection needing treatment throughout the body.
- Have active cancer spread to the brain or spinal cord, or another cancer that is growing or needed treatment in the past 3 years.
- Have had certain past cancer treatments or recent treatments, a live vaccine in the past 30 days, or medicines that are not allowed in the study.
- Have had major surgery or a serious injury in the past 4 weeks, have not healed well from surgery, or have had a tissue or organ transplant from another person.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma * Is not expected to require tumor resection during the treatment course * Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines * Core/excisional biopsy of a tumor lesion not previously irradiated has been provided * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline * Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible * Has adequate organ function * Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR) * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention * Has a life expectancy of at least 6 months * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has squamous cell or undifferentiated gastroesophageal cancer. * Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma * Has experienced weight loss \>20% over 3 months before the first dose of study intervention * Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has Grade ≥2 peripheral neuropathy * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention * Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment * Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents * Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and/or a topoisomerase I inhibitor-based chemotherapy * Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR) * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening * Has an active infection requiring systemic therapy * Has concurrent active hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus \[HCV\] Ab positive and detectable HCV ribonucleic acid \[RNA\] infection or a known history of hepatitis B and/or C infection * Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study * Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication * Has poorly controlled diarrhea * Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention * Has history of allogeneic tissue/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Study sites (8)
AZ
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927) · Tucson, AZ 85719Study Coordinator · Study contact · 520-621-2449More trials in Tucson
CA
- UCLA Hematology/Oncology - Santa Monica ( Site 6905) · Los Angeles, CA 90404Study Coordinator · Study contact · 310-570-1453More trials in Los Angeles
KY
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900) · Louisville, KY 40202More trials in Louisville
MI
- The Cancer and Hematology Centers ( Site 6912) · Grand Rapids, MI 49503Study Coordinator · Study contact · 616-975-3065More trials in Grand Rapids
NY
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925) · East Syracuse, NY 13057Study Coordinator · Study contact · 315-472-7504More trials in East Syracuse
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907) · New York, NY 10032More trials in New York
PA
- UPMC Hillman Cancer Center-UPMC ( Site 6904) · Pittsburgh, PA 15232Study Coordinator · Study contact · 816-898-9413More trials in Pittsburgh
TX
- University of Texas MD Anderson Cancer Center ( Site 6920) · Houston, TX 77030Study Coordinator · Study contact · 833-589-0868More trials in Houston