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

Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic 1L gastroesophageal adenocarcinoma

• Is not expected to require tumor resection during the treatment course

• 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

• Core/excisional biopsy of a tumor lesion not previously irradiated has been provided

• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to \<Grade 1 or baseline

• Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible

• Has adequate organ function

• Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blind independent review committee (BICR)

• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention

• Has a life expectancy of at least 6 months

Locations
United States
Arizona
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
RECRUITING
Tucson
California
UCLA Hematology/Oncology - Santa Monica ( Site 6905)
RECRUITING
Los Angeles
Kentucky
Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
RECRUITING
Louisville
Michigan
The Cancer and Hematology Centers ( Site 6912)
RECRUITING
Grand Rapids
New York
Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
RECRUITING
East Syracuse
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
COMPLETED
New York
Pennsylvania
UPMC Hillman Cancer Center-UPMC ( Site 6904)
RECRUITING
Pittsburgh
Texas
University of Texas MD Anderson Cancer Center ( Site 6920)
RECRUITING
Houston
Other Locations
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 6303)
RECRUITING
Natal
Hospital Nossa Senhora da Conceição ( Site 6301)
RECRUITING
Porto Alegre
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
RECRUITING
São Paulo
Chile
Bradford Hill Norte ( Site 6407)
RECRUITING
Antofagasta
Clínica Puerto Montt ( Site 6409)
RECRUITING
Port Montt
Bradfordhill-Clinical Area ( Site 6401)
RECRUITING
Santiago
Centro de Oncología de Precisión-Oncology ( Site 6404)
RECRUITING
Santiago
Clínica UC San Carlos de Apoquindo ( Site 6405)
RECRUITING
Santiago
FALP-UIDO ( Site 6400)
RECRUITING
Santiago
Centro de Investigación del Maule ( Site 6408)
RECRUITING
Talca
China
Beijing Cancer hospital-Digestive Oncology ( Site 5500)
RECRUITING
Beijing
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
RECRUITING
Fuzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University ( Site 5514)
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center ( Site 5513)
RECRUITING
Shanghai
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
RECRUITING
Ürümqi
The First Affiliated hospital of Xiamen University ( Site 5503)
RECRUITING
Xiamen
Henan Cancer Hospital ( Site 5504)
RECRUITING
Zhengzhou
France
CHU-BREST Cavale Blanche ( Site 5104)
RECRUITING
Brest
CIC. ( Site 5100)
RECRUITING
Lille
Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
RECRUITING
Paris
Germany
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
RECRUITING
Düsseldorf
Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 6807)
RECRUITING
Hamburg
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 5207)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
RECRUITING
Milan
Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
RECRUITING
Oslo
Republic of Korea
Asan Medical Center-Department of Oncology ( Site 5901)
RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
RECRUITING
Seoul
Switzerland
Kantonsspital Graubünden-Medizin ( Site 6700)
RECRUITING
Chur
Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
RECRUITING
Geneva
Taiwan
China Medical University Hospital ( Site 6007)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 6001)
RECRUITING
Tainan
National Taiwan University Hospital-Oncology ( Site 6000)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 6005)
RECRUITING
Taipei
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2029-04-12
Participants
Target number of participants: 160
Treatments
Active_comparator: Pembrolizumab plus Chemotherapy
Participants will receive pembrolizumab 400 mg via intravenous (IV) injection on day 1 of every 6 week cycle (Q6W) for up to 18 cycles (up to \~2 years) AND investigator's choice of CAPOX chemotherapy (capecitabine 1000 mg/m\^2 orally twice daily for 14 days every 3 weeks (Q3W) and oxaliplatin 130 mg/m\^2 via IV infusion Q3W) OR mFOLFOX6 chemotherapy (oxaliplatin 85 mg/m\^2 via IV infusion Q3W; 5-Fluorouracil (5-FU) 400 mg/\^2 via bolus IV plus 2400 mg/m\^2 continuous IV once every 2 weeks (Q2W); and leucovorin 400 mg/m\^2 via IV infusion Q2W OR levoleucovorin 200 mg/m\^2 Q2W).
Experimental: Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy
Participants will receive sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to \~2 years) AND investigator's choice of capecitabine 1000 mg/m\^2 orally twice daily for 14 days Q3W OR 5-FU 400 mg/\^2 via bolus IV plus 2400 mg/m\^2 continuous IV once Q2W AND leucovorin 400 mg/m\^2 via IV infusion Q2W OR levoleucovorin 200 mg/m\^2 Q2W.
Experimental: Pembrolizumab plus Patritumab Deruxtecan plus Chemotherapy
Participants will receive patritumab deruxtecan via IV infusion on Days 1 and 22 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to \~2 years) AND investigator's choice of capecitabine 1000 mg/m\^2 orally twice daily for 14 days Q3W OR 5-FU 400 mg/\^2 via bolus IV plus 2400 mg/m\^2 continuous IV once Q2W AND leucovorin 400 mg/m\^2 via IV infusion Q2W OR levoleucovorin 200 mg/m\^2 Q2W.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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