A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of MK-2870 Plus Paclitaxel as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

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 efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

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 treated, 2L (received first line (1L) treatment) gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma

• Has metastatic disease or locally advanced, unresectable disease

• Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum/fluoropyrimidine doublet with or without immunotherapy

• Participants with gastroesophageal adenocarcinoma that is known to be human epidermal growth factor receptor 2 (HER2)/neu positive are excluded. Participants with unknown HER2 status are eligible.

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

• AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable.

• Has Eastern Cooperative Oncology Group performance status of 0 or 1

• Has a life expectancy of at least 3 months

• Participants 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.

• Participants with 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.

Locations
United States
Arizona
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)
RECRUITING
Tucson
California
UCLA Hematology/Oncology - Santa Monica ( Site 8905)
RECRUITING
Los Angeles
Kentucky
Norton Cancer Institute - Downtown ( Site 8900)
RECRUITING
Louisville
Michigan
The Cancer and Hematology Centers ( Site 8912)
RECRUITING
Grand Rapids
New York
Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)
RECRUITING
East Syracuse
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)
COMPLETED
New York
Pennsylvania
UPMC Hillman Cancer Center-UPMC ( Site 8904)
RECRUITING
Pittsburgh
Texas
University of Texas MD Anderson Cancer Center ( Site 8920)
RECRUITING
Houston
Other Locations
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 8303)
RECRUITING
Natal
Hospital Nossa Senhora da Conceição ( Site 8301)
RECRUITING
Porto Alegre
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304)
RECRUITING
São Paulo
Chile
Bradford Hill Norte ( Site 8407)
RECRUITING
Antofagasta
Clínica Puerto Montt ( Site 8409)
RECRUITING
Port Montt
Bradfordhill-Clinical Area ( Site 8401)
RECRUITING
Santiago
Centro de Oncología de Precisión-Oncology ( Site 8404)
RECRUITING
Santiago
Clínica UC San Carlos de Apoquindo ( Site 8405)
RECRUITING
Santiago
FALP-UIDO ( Site 8400)
RECRUITING
Santiago
Centro de Investigación del Maule ( Site 8408)
RECRUITING
Talca
China
Beijing Cancer hospital-Digestive Oncology ( Site 7500)
RECRUITING
Beijing
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 7501)
RECRUITING
Fuzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 7510)
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University ( Site 7514)
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center ( Site 7513)
RECRUITING
Shanghai
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506)
RECRUITING
Ürümqi
The First Affiliated hospital of Xiamen University ( Site 7503)
RECRUITING
Xiamen
Henan Cancer Hospital ( Site 7504)
RECRUITING
Zhengzhou
France
Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi ( Site 7104)
RECRUITING
Brest
CIC. ( Site 7100)
RECRUITING
Lille
Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 7102)
RECRUITING
Paris
Germany
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 8802)
RECRUITING
Düsseldorf
Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 8807)
RECRUITING
Hamburg
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 7207)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 7200)
RECRUITING
Milan
Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 8501)
RECRUITING
Oslo
Republic of Korea
Asan Medical Center-Department of Oncology ( Site 7901)
RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 7900)
RECRUITING
Seoul
Switzerland
Kantonsspital Graubünden-Medizin ( Site 8700)
RECRUITING
Chur
Hôpitaux Universitaires de Genève (HUG) ( Site 8701)
RECRUITING
Geneva
Taiwan
China Medical University Hospital ( Site 8007)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 8001)
RECRUITING
Tainan City
National Taiwan University Hospital-Oncology ( Site 8000)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 8005)
RECRUITING
Taipei
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2028-10-27
Participants
Target number of participants: 90
Treatments
Active_comparator: Ramucirumab + Paclitaxel
Participants will receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to \~60 weeks plus paclitaxel at 80 mg/M\^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) for up to \~60 weeks.
Experimental: Sacituzumab Tirumotecan + Paclitaxel
Following a 28-day run-in with sacituzumab tirumotecan at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants will receive paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) up to \~60 weeks plus sacituzumab tirumotecan at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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