OncoMatch/Clinical Trials/NCT06469944
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)
Is NCT06469944 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments for gastroesophageal junction.
Treatment: Pembrolizumab · Sacituzumab Tirumotecan (sac-TMT) · Capecitabine · Leucovorin · Levoleucovorin · 5-Fluorouracil (5-FU) · Oxaliplatin · Patritumab Deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type (absence)
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma
Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma
Cannot have received: TROP2-targeted agent
Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted ... agent
Cannot have received: anti-HER3 targeted agent
Has received prior treatment with ... anti-human epidermal growth factor receptor 3 (HER3) targeted agents
Cannot have received: topoisomerase I inhibitor-based antibody-drug conjugate
Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC)
Cannot have received: topoisomerase I inhibitor-based chemotherapy
Has received prior treatment with ... topoisomerase I inhibitor-based chemotherapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
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)
Lab requirements
Blood counts
Has adequate organ function
Kidney function
Has adequate organ function
Liver function
Has adequate organ function
Has adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927) · Tucson, Arizona
- UCLA Hematology/Oncology - Santa Monica ( Site 6905) · Los Angeles, California
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900) · Louisville, Kentucky
- The Cancer and Hematology Centers ( Site 6912) · Grand Rapids, Michigan
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925) · East Syracuse, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06469944 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma, TROP2-targeted agent, anti-HER3 targeted agent disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages