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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona diagnoza raka żołądka, połączenia żołądka i przełyku lub przełyku, który nie rozprzestrzenia się na inne organy (lub rozprzestrzenia się, ale nie można go usunąć chirurgicznie)
- •Nowotwór bez markerów HER2 (potwierdzone badaniem laboratoryjnym)
- •Wcześnie pobrana próbka tkanki nowotworowej do badań
- •Odporność organizmu wystarczająca do tolerowania leczenia (wydolność organów)
- •Możliwość mierzenia rozmiaru nowotworu za pomocą badań obrazowych
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (skala ECOG 0-1)
- •Spodziewana długość życia co najmniej 6 miesięcy
- •Jeśli pacjent ma hepatitę B lub C albo HIV - muszą być kontrolowane odpowiednim leczeniem
✗ Disqualifies
- •Rak o budowie płaskonaborenkowej lub niezróżnicowanej
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (51)
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
Tucson, United States
UCLA Hematology/Oncology - Santa Monica ( Site 6905)
Los Angeles, United States
Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
Louisville, United States
The Cancer and Hematology Centers ( Site 6912)
Grand Rapids, United States
Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
East Syracuse, United States
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
New York, United States
UPMC Hillman Cancer Center-UPMC ( Site 6904)
Pittsburgh, United States
University of Texas MD Anderson Cancer Center ( Site 6920)
Houston, United States
Liga Norte Riograndense Contra o Câncer ( Site 6303)
Natal, Brazil
Hospital Nossa Senhora da Conceição ( Site 6301)
Porto Alegre, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)
São Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
São Paulo, Brazil
Clínica Puerto Montt ( Site 6409)
Port Montt, Chile
Centro de Investigación del Maule ( Site 6408)
Talca, Chile
FALP-UIDO ( Site 6400)
Santiago, Chile
Centro de Oncología de Precisión-Oncology ( Site 6404)
Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 6405)
Santiago, Chile
Bradfordhill-Clinical Area ( Site 6401)
Santiago, Chile
Bradford Hill Norte ( Site 6407)
Antofagasta, Chile
Beijing Cancer hospital-Digestive Oncology ( Site 5500)
Beijing, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
Fuzhou, China
The First Affiliated hospital of Xiamen University ( Site 5503)
Xiamen, China
Henan Cancer Hospital ( Site 5504)
Zhengzhou, China
The First Affiliated Hospital of Nanchang University ( Site 5514)
Nanchang, China
Fudan University Shanghai Cancer Center ( Site 5513)
Shanghai, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
Ürümqi, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
Hangzhou, China
CHU-BREST Cavale Blanche ( Site 5104)
Brest, France
CIC. ( Site 5100)
Lille, France
Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
Paris, France
NCT-Department of Medical Oncology ( Site 6809)
Heidelberg, Germany
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
Düsseldorf, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 6806)
Dresden, Germany
Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 6807)
Hamburg, Germany
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)
Meldola, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
Milan, Italy
Azienda Ospedaliero Universitaria Pisana ( Site 5206)
Pisa, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 5202)
Milan, Italy
Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
Oslo, Norway
Asan Medical Center-Department of Oncology ( Site 5901)
Seoul, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
Seoul, South Korea
Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
Geneva, Switzerland
Kantonsspital Graubünden-Medizin ( Site 6700)
Chur, Switzerland
China Medical University Hospital ( Site 6007)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 6001)
Tainan, Taiwan
National Taiwan University Hospital-Oncology ( Site 6000)
Taipei, Taiwan
Taipei Veterans General Hospital ( Site 6005)
Taipei, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 6102)
Bangkoknoi, Thailand
Chulalongkorn Hospital ( Site 6104)
Pathumwan, Thailand
Ramathibodi Hospital ( Site 6103)
Ratchathewi, Thailand
Songklanagarind hospital ( Site 6101)
Hat Yai, Thailand
Trial contact
Toll Free Number
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/8/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.