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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

August 7, 2024

Primary Completion Date

December 28, 2026

Study Completion Date

October 27, 2028

Conditions
Gastroesophageal JunctionGastroesophageal AdenocarcinomaEsophageal NeoplasmsEsophageal Cancer
Interventions
BIOLOGICAL

Ramucirumab

8 mg/kg IV Infusion

DRUG

Paclitaxel

80 mg/M\^2 IV infusion

BIOLOGICAL

Sacituzumab Tirumotecan

3 mg/kg or 4 mg/kg IV Infusion

DRUG

Rescue Medications

Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent).

Trial Locations (42)

112

RECRUITING

Taipei Veterans General Hospital ( Site 8005), Taipei

704

RECRUITING

National Cheng Kung University Hospital ( Site 8001), Tainan City

1211

RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 8701), Geneva

7000

RECRUITING

Kantonsspital Graubünden-Medizin ( Site 8700), Chur

10032

COMPLETED

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

10048

RECRUITING

National Taiwan University Hospital-Oncology ( Site 8000), Taipei

13057

RECRUITING

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

15232

RECRUITING

UPMC Hillman Cancer Center-UPMC ( Site 8904), Pittsburgh

20133

RECRUITING

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

20249

RECRUITING

Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 8807), Hamburg

29200

RECRUITING

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

40202

RECRUITING

Norton Cancer Institute - Downtown ( Site 8900), Louisville

40225

RECRUITING

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

47014

RECRUITING

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

49503

RECRUITING

The Cancer and Hematology Centers ( Site 8912), Grand Rapids

59037

RECRUITING

CIC. ( Site 7100), Lille

75013

RECRUITING

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

77030

RECRUITING

University of Texas MD Anderson Cancer Center ( Site 8920), Houston

85719

RECRUITING

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

90404

RECRUITING

UCLA Hematology/Oncology - Santa Monica ( Site 8905), Los Angeles

100142

RECRUITING

Beijing Cancer hospital-Digestive Oncology ( Site 7500), Beijing

200032

RECRUITING

Fudan University Shanghai Cancer Center ( Site 7513), Shanghai

310016

RECRUITING

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

330209

RECRUITING

The First Affiliated Hospital of Nanchang University ( Site 7514), Nanchang

350025

RECRUITING

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

361003

RECRUITING

The First Affiliated hospital of Xiamen University ( Site 7503), Xiamen

404332

RECRUITING

China Medical University Hospital ( Site 8007), Taichung

450000

RECRUITING

Henan Cancer Hospital ( Site 7504), Zhengzhou

841100

RECRUITING

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506), Ürümqi

1240000

RECRUITING

Bradford Hill Norte ( Site 8407), Antofagasta

3481349

RECRUITING

Centro de Investigación del Maule ( Site 8408), Talca

5507642

RECRUITING

Clínica Puerto Montt ( Site 8409), Port Montt

7500921

RECRUITING

FALP-UIDO ( Site 8400), Santiago

7560908

RECRUITING

Centro de Oncología de Precisión-Oncology ( Site 8404), Santiago

7620002

RECRUITING

Clínica UC San Carlos de Apoquindo ( Site 8405), Santiago

8420383

RECRUITING

Bradfordhill-Clinical Area ( Site 8401), Santiago

59062-000

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 8303), Natal

91350-200

RECRUITING

Hospital Nossa Senhora da Conceição ( Site 8301), Porto Alegre

03102-002

RECRUITING

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

0379

RECRUITING

Oslo universitetssykehus, Radiumhospitalet ( Site 8501), Oslo

05505

RECRUITING

Asan Medical Center-Department of Oncology ( Site 7901), Seoul

06351

RECRUITING

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

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY