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Study identifier: NCT06469944 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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)

Condition: Gastroesophageal Junction · Gastroesophageal Adenocarcinoma · Esophageal Neoplasms  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 1/Phase 2
Planned participants160
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Toll Free Number  ·  1-888-577-8839  ·  Trialsites@msd.com

Always discuss trial participation with your own doctor first.

Locations (51)

University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)Tucson, Arizona, United StatesRecruiting
UCLA Hematology/Oncology - Santa Monica ( Site 6905)Los Angeles, California, United StatesRecruiting
Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)Louisville, Kentucky, United StatesCompleted
The Cancer and Hematology Centers ( Site 6912)Grand Rapids, Michigan, United StatesRecruiting
Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)East Syracuse, New York, United StatesRecruiting
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)New York, New York, United StatesCompleted
UPMC Hillman Cancer Center-UPMC ( Site 6904)Pittsburgh, Pennsylvania, United StatesRecruiting
University of Texas MD Anderson Cancer Center ( Site 6920)Houston, Texas, United StatesRecruiting
Liga Norte Riograndense Contra o Câncer ( Site 6303)Natal, Rio Grande do Norte, BrazilRecruiting
Hospital Nossa Senhora da Conceição ( Site 6301)Porto Alegre, Rio Grande do Sul, BrazilRecruiting
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)São Paulo, BrazilRecruiting
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)São Paulo, BrazilRecruiting

+ 39 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06469944