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RecruitingPhase 1Phase 2NCT06445972

Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Sponsor

Merck Sharp & Dohme LLC

Enrollment

210 participants

Start Date

Aug 7, 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 efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (Keymaker-U06 substudy 06D) tests combination treatments in patients with stomach or esophageal cancer (adenocarcinoma type) that has spread and is being treated in the second line — meaning the first round of treatment has already been tried. It focuses on HER2-negative cancers. **You may be eligible if...** - You have confirmed gastric, gastroesophageal junction, or esophageal adenocarcinoma that has spread or cannot be removed - Your cancer progressed during or after a first-line platinum/fluoropyrimidine-based treatment - Your tumor has been confirmed HER2-negative - You are in good general health (ECOG 0–1) with a life expectancy of at least 3 months - You can provide a fresh biopsy from a non-irradiated tumor site **You may NOT be eligible if...** - Your cancer is squamous cell or undifferentiated type - You have lost more than 20% of your body weight in the 3 months before the first dose - Your previous treatment side effects have not resolved to mild or baseline levels 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

BIOLOGICALRamucirumab

8 mg/kg IV Infusion

DRUGPaclitaxel

80 mg/M\^2 IV infusion

BIOLOGICALSacituzumab Tirumotecan

3 mg/kg or 4 mg/kg IV Infusion

DRUGRescue Medications

Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

BIOLOGICALHER3-DXd

IV Infusion

Locations(44)

University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)

Tucson, Arizona, United States

UCLA Hematology/Oncology - Santa Monica ( Site 8905)

Los Angeles, California, United States

Norton Cancer Institute - Downtown ( Site 8900)

Louisville, Kentucky, United States

The Cancer and Hematology Centers ( Site 8912)

Grand Rapids, Michigan, United States

Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)

East Syracuse, New York, United States

Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)

New York, New York, United States

UPMC Hillman Cancer Center-UPMC ( Site 8904)

Pittsburgh, Pennsylvania, United States

University of Texas MD Anderson Cancer Center ( Site 8920)

Houston, Texas, United States

Liga Norte Riograndense Contra o Câncer ( Site 8303)

Natal, Rio Grande do Norte, Brazil

Hospital Nossa Senhora da Conceição ( Site 8301)

Porto Alegre, Rio Grande do Sul, Brazil

IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304)

São Paulo, São Paulo, Brazil

Clínica Puerto Montt ( Site 8409)

Port Montt, Los Lagos Region, Chile

Centro de Investigación del Maule ( Site 8408)

Talca, Maule Region, Chile

FALP-UIDO ( Site 8400)

Santiago, Region M. de Santiago, Chile

Centro de Oncología de Precisión-Oncology ( Site 8404)

Santiago, Region M. de Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 8405)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 8401)

Santiago, Region M. de Santiago, Chile

Bradford Hill Norte ( Site 8407)

Antofagasta, Chile

Beijing Cancer hospital-Digestive Oncology ( Site 7500)

Beijing, Beijing Municipality, China

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 7501)

Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University ( Site 7503)

Xiamen, Fujian, China

Henan Cancer Hospital ( Site 7504)

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University ( Site 7514)

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center ( Site 7513)

Shanghai, Shanghai Municipality, China

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506)

Ürümqi, Xinjiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 7510)

Hangzhou, Zhejiang, China

Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi ( Site 7104)

Brest, Finistere, France

CIC. ( Site 7100)

Lille, Nord, France

Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 7102)

Paris, Île-de-France Region, France

NCT-Department of Medical Oncology ( Site 8809)

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 8802)

Düsseldorf, North Rhine-Westphalia, Germany

Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 8807)

Hamburg, Germany

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 7207)

Meldola, Emilia-Romagna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 7200)

Milan, Lombardy, Italy

Ospedale San Raffaele-Oncologia Medica ( Site 7202)

Milan, Italy

Oslo universitetssykehus, Radiumhospitalet ( Site 8501)

Oslo, Norway

Asan Medical Center-Department of Oncology ( Site 7901)

Seoul, South Korea

Samsung Medical Center-Division of Hematology/Oncology ( Site 7900)

Seoul, South Korea

Hôpitaux Universitaires de Genève (HUG) ( Site 8701)

Geneva, Canton of Geneva, Switzerland

Kantonsspital Graubünden-Medizin ( Site 8700)

Chur, Kanton Graubünden, Switzerland

China Medical University Hospital ( Site 8007)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 8001)

Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 8000)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 8005)

Taipei, Taiwan

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