A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 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 sacituzumab tirumotecan 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 sacituzumab tirumotecan 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

• Has gastroesophageal adenocarcinoma that is known to be human epidermal growth factor receptor 2 (HER2)/neu-positive are excluded. HER2 status is not required if HER2/neu testing is not mandatory per local standard of care (SOC)

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

• Has not had prior systemic therapy administered in the recurrent or metastatic setting

• Has provided an archival tumor tissue sample or most recently obtained core, or incisional, or excisional biopsy for a tumor lesion

• 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 assessed within 3 days before allocation/randomization.

• Has a life expectancy of at least 6 months

• Who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.

• Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

• Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)

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 City
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: 130
Treatments
Active_comparator: Pembrolizumab plus Chemotherapy
Participants will receive pembrolizumab 400 mg via intravenous (IV) injection on day 1 of every 6 week cycle 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-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 of each 6 week cycle until discontinuation, pembrolizumab 400 mg via IV injection on day 1 of every 6 week cycle 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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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