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(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: Administered via intravenous (IV) infusion.
Sacituzumab Tirumotecan (sac-TMT): Administered via IV infusion.
Capecitabine: Administered via oral tablet.
Leucovorin: Administered via IV infusion.
Levoleucovorin: Administered via IV infusion.
5-Fluorouracil (5-FU): Administered via IV infusion
Oxaliplatin: Administered via IV infusion
Patritumab Deruxtecan: Administered via IV infusion
Study 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
Primary outcome measure(s)
- Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) — Up to approximately 28 days
DLTs are defined as any treatment-emergent adverse events (TEAEs) not attributable to disease or disease-related processes that occur during the DLT evaluation period and are a Grade 3 or higher according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0. The percentage of participants who experience at least one DLT will be reported. - Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) — Up to approximately 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. - Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE — Up to approximately 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. - Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 28 months
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927) | Tucson | Arizona | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 6905) | Los Angeles | California | Recruiting |
| Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900) | Louisville | Kentucky | Completed |
| The Cancer and Hematology Centers ( Site 6912) | Grand Rapids | Michigan | Recruiting |
| Hematology-Oncology Associates of Central NY, P.C. ( Site 6925) | East Syracuse | New York | Recruiting |
| Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907) | New York | New York | Completed |
| UPMC Hillman Cancer Center-UPMC ( Site 6904) | Pittsburgh | Pennsylvania | Recruiting |
| University of Texas MD Anderson Cancer Center ( Site 6920) | Houston | Texas | Recruiting |
| Liga Norte Riograndense Contra o Câncer ( Site 6303) | Natal | Rio Grande do Norte | Recruiting |
| Hospital Nossa Senhora da Conceição ( Site 6301) | Porto Alegre | Rio Grande do Sul | Recruiting |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300) | São Paulo | Brazil | Recruiting |
| IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304) | São Paulo | Brazil | Recruiting |
| Clínica Puerto Montt ( Site 6409) | Port Montt | Los Lagos Region | Recruiting |
| Centro de Investigación del Maule ( Site 6408) | Talca | Maule Region | Completed |
| FALP-UIDO ( Site 6400) | Santiago | Region M. de Santiago | Recruiting |
| Centro de Oncología de Precisión-Oncology ( Site 6404) | Santiago | Region M. de Santiago | Recruiting |
| Clínica UC San Carlos de Apoquindo ( Site 6405) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill-Clinical Area ( Site 6401) | Santiago | Region M. de Santiago | Recruiting |
| Bradford Hill Norte ( Site 6407) | Antofagasta | Chile | Recruiting |
| Beijing Cancer hospital-Digestive Oncology ( Site 5500) | Beijing | Beijing Municipality | Recruiting |
| The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501) | Fuzhou | Fujian | Recruiting |
| The First Affiliated hospital of Xiamen University ( Site 5503) | Xiamen | Fujian | Recruiting |
| Henan Cancer Hospital ( Site 5504) | Zhengzhou | Henan | Recruiting |
| The First Affiliated Hospital of Nanchang University ( Site 5514) | Nanchang | Jiangxi | Recruiting |
| Fudan University Shanghai Cancer Center ( Site 5513) | Shanghai | Shanghai Municipality | Recruiting |
| Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506) | Ürümqi | Xinjiang | Active Not Recruiting |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510) | Hangzhou | Zhejiang | Recruiting |
| CHU-BREST Cavale Blanche ( Site 5104) | Brest | Finistere | Recruiting |
| CIC. ( Site 5100) | Lille | Nord | Recruiting |
| Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102) | Paris | Île-de-France Region | Recruiting |
| NCT-Department of Medical Oncology ( Site 6809) | Heidelberg | Baden-Wurttemberg | Recruiting |
| HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807) | Erdgeschoss | Free and Hanseatic City of Hamburg | Recruiting |
| Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802) | Düsseldorf | North Rhine-Westphalia | Recruiting |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207) | Meldola | Emilia-Romagna | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200) | Milan | Lombardy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana ( Site 5206) | Pisa | Tuscany | Recruiting |
| Ospedale San Raffaele-Oncologia Medica ( Site 5202) | Milan | Italy | Recruiting |
| Oslo universitetssykehus, Radiumhospitalet ( Site 6501) | Oslo | Norway | Recruiting |
| Asan Medical Center-Department of Oncology ( Site 5901) | Seoul | South Korea | Recruiting |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 5900) | Seoul | South Korea | Recruiting |
+ 10 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06469944 on ClinicalTrials.gov ↗ ← All trials in China