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RecruitingPhase 1Phase 2NCT06469944

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

160 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal CancerEsophageal NeoplasmsGastroesophageal JunctionGastroesophageal Adenocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination added on top of pembrolizumab (an immunotherapy) and chemotherapy for people with advanced stomach or gastroesophageal junction cancer that has not been treated before. **You may be eligible if...** - You have newly diagnosed, untreated locally advanced or metastatic stomach/gastroesophageal junction cancer confirmed by biopsy - Your tumor does not overexpress the HER2 protein - You have not had surgery planned to remove the tumor - Any side effects from previous (unrelated) cancer therapies have mostly resolved **You may NOT be eligible if...** - You have already received treatment for your advanced stomach cancer - Your tumor is HER2-positive - You cannot tolerate chemotherapy or immunotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab

Administered via intravenous (IV) infusion.

BIOLOGICALSacituzumab Tirumotecan (sac-TMT)

Administered via IV infusion.

DRUGCapecitabine

Administered via oral tablet.

DRUGLeucovorin

Administered via IV infusion.

DRUGLevoleucovorin

Administered via IV infusion.

DRUG5-Fluorouracil (5-FU)

Administered via IV infusion

DRUGOxaliplatin

Administered via IV infusion

BIOLOGICALPatritumab Deruxtecan

Administered via IV infusion

Locations(50)

University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)

Tucson, Arizona, United States

UCLA Hematology/Oncology - Santa Monica ( Site 6905)

Los Angeles, California, United States

Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)

Louisville, Kentucky, United States

The Cancer and Hematology Centers ( Site 6912)

Grand Rapids, Michigan, United States

Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)

East Syracuse, New York, United States

Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)

New York, New York, United States

UPMC Hillman Cancer Center-UPMC ( Site 6904)

Pittsburgh, Pennsylvania, United States

University of Texas MD Anderson Cancer Center ( Site 6920)

Houston, Texas, United States

Liga Norte Riograndense Contra o Câncer ( Site 6303)

Natal, Rio Grande do Norte, Brazil

Hospital Nossa Senhora da Conceição ( Site 6301)

Porto Alegre, Rio Grande do Sul, 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, Los Lagos Region, Chile

Centro de Investigación del Maule ( Site 6408)

Talca, Maule Region, Chile

FALP-UIDO ( Site 6400)

Santiago, Region M. de Santiago, Chile

Centro de Oncología de Precisión-Oncology ( Site 6404)

Santiago, Region M. de Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 6405)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 6401)

Santiago, Region M. de Santiago, Chile

Bradford Hill Norte ( Site 6407)

Antofagasta, Chile

Beijing Cancer hospital-Digestive Oncology ( Site 5500)

Beijing, Beijing Municipality, China

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)

Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University ( Site 5503)

Xiamen, Fujian, China

Henan Cancer Hospital ( Site 5504)

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University ( Site 5514)

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center ( Site 5513)

Shanghai, Shanghai Municipality, China

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)

Ürümqi, Xinjiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)

Hangzhou, Zhejiang, China

CHU-BREST Cavale Blanche ( Site 5104)

Brest, Finistere, France

CIC. ( Site 5100)

Lille, Nord, France

Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)

Paris, Île-de-France Region, France

NCT-Department of Medical Oncology ( Site 6809)

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)

Düsseldorf, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 6806)

Dresden, Saxony, 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, Emilia-Romagna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Pisana ( Site 5206)

Pisa, Tuscany, 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, Canton of Geneva, Switzerland

Kantonsspital Graubünden-Medizin ( Site 6700)

Chur, Kanton Graubünden, 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, Bangkok, Thailand

Chulalongkorn Hospital ( Site 6104)

Pathumwan, Bangkok, Thailand

Songklanagarind hospital ( Site 6101)

Hat Yai, Changwat Songkhla, Thailand

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