RecruitingPhase 1 / Phase 2

Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

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 the safety and effects of two drug pairs: sacituzumab tirumotecan plus paclitaxel, and HER3-DXD plus ramucirumab. Each is compared with ramucirumab plus paclitaxel. It is for people with advanced cancer of the stomach, food pipe, or where they meet, whose cancer got worse during or after their first treatment.

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have adenocarcinoma, a type of cancer, in the stomach, food pipe, or where they meet, confirmed by a tissue or cell test.
  • Have cancer that has spread or has grown nearby and cannot be removed by surgery.
  • Have cancer that got worse during or after first treatment with platinum and fluoropyrimidine chemotherapy, with or without immune therapy.
  • Have a tumor that tests negative for HER2, a protein that can help cancer grow.
  • Can provide a tumor sample taken after the most recent cancer drug treatment, from an area not treated with radiation.
  • Have only mild or no remaining side effects from past cancer treatment. Hair loss, loss of skin color, and hormone problems controlled with replacement hormones are allowed.
  • Can do most daily activities with little or no help and are expected to live at least 3 months.
  • If you have hepatitis B, have at least 4 weeks of antiviral treatment and no detectable virus. Past hepatitis C must have no detectable virus, and HIV must be well controlled with medicine.

Who can't join

  • Have squamous cell or undifferentiated cancer of the stomach or food pipe, rather than adenocarcinoma.
  • Lost more than 20% of body weight in the past 3 months, have severe eye problems, or have moderate or worse nerve damage in the arms or legs.
  • Have a history of inflammatory bowel disease, a blocked bowel, certain major bowel surgery, or a recent serious wound, stomach ulcer, or broken bone.
  • Have serious uncontrolled heart or blood vessel disease, uncontrolled blood pressure of 150/90 or higher, or a recent heart attack, stroke, or major blood clot.
  • Have major bleeding problems, recent bleeding or a hole in the digestive tract, or take certain blood thinners or long-term anti-inflammatory medicines.
  • Had certain earlier targeted cancer drugs or chemotherapy, recent cancer treatment or experimental treatment, a recent live vaccine, or recent major surgery.
  • Have another cancer that is growing or needed treatment in the past 3 years, with some exceptions, or active cancer spread to the brain, spinal cord, or their lining.
  • Have an infection needing treatment, active hepatitis B and C together, certain lung inflammation, or a severe allergy to the study drugs or another biologic treatment.

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 treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma * Has metastatic disease or locally advanced, unresectable disease * Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum/fluoropyrimidine doublet with or without immunotherapy * Tumor tissue must be confirmed as negative for HER2 expression (IHC 0/1+ or IHC2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines * Can provide a core/excisional biopsy of a tumor lesion not previously irradiated (collected from a biopsy performed after the most recent systemic anticancer therapy regimen) * AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable * Has Eastern Cooperative Oncology Group performance status of 0 or 1 * Has a life expectancy of at least 3 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 experienced weight loss \>20% over 3 months before the first dose of study intervention * Has 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 a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to allocation/randomization * Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to allocation/randomization * Has uncontrolled arterial hypertension ≥150/≥90 mm mercury (Hg) * Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment * Has undergone major surgery within 28 days prior to allocation/randomization, or central venous access device placement within 7 days prior to allocation/randomization or planned major surgery following initiation of study treatment * Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents * Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents * Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to allocation/randomization * Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry * Has history of GI perforation and/or fistulae within 6 months prior to allocation/randomization * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)- or HER3-targeted agent, topoisomerase 1 inhibitor-based ADC and/or a topoisomerase 1 inhibitor-based chemotherapy, or any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or the vascular endothelial growth factor receptor (VEGFR) signaling pathways * Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention * 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. Administration of killed vaccines is allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded * Has known active central nervous system metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid) infection * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD or pneumonitis cannot be ruled out by imaging at screening * Has severe hypersensitivity (Grade ≥3) to MK-2870, or HER3-DXd, any of their excipients, and/or to another biologic therapy * Has not adequately recovered from major surgery or have ongoing surgical complications

Study sites (8)

AZ

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927) · Tucson, AZ 85719Study Coordinator · Study contact · 520-621-2449More trials in Tucson

CA

KY

MI

NY

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 8925) · 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 8907) · New York, NY 10032More trials in New York

PA

TX