Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Carcinoma, Renal Cell
Interventions
BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a dose of 400 mg Q6W

BIOLOGICAL

Favezelimab/Pembrolizumab

Administered via IV infusion at a dose of 800 mg/200 mg Q3W

DRUG

Belzutifan

Administered via oral tablet at a dose of 120 mg QD

DRUG

Lenvatinib

Administered via oral capsule at a dose of 20 mg QD

BIOLOGICAL

Pembrolizumab/Quavonlimab

Administered via IV infusion at a dose of 400 mg/25 mg Q6W

DRUG

Vibostolimab/Pembrolizumab

Administered via IV infusion at a dose of 200 mg/200 mg Q6W

Trial Locations (55)

1023

Auckland City Hospital ( Site 1700), Auckland

1122

Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301), Budapest

2148

Western Sydney Local Health District ( Site 1601), Blacktown

2217

St George Hospital ( Site 1602), Kogarah

3084

Austin Health ( Site 1600), Heidelberg

4029

Royal Brisbane and Women s Hospital ( Site 1603), Herston

10016

Laura and Isaac Perlmutter Cancer Center ( Site 1016), New York

10065

Memorial Sloan Kettering Cancer Center ( Site 1002), New York

15232

UPMC Cancer Center/Hillman Cancer Center ( Site 1017), Pittsburgh

27710

Duke Cancer Institute ( Site 1015), Durham

28034

Hospital Universitario Ramon y Cajal ( Site 1301), Madrid

31059

Institut Claudius Regaud ( Site 1200), Toulouse

48202

Henry Ford Health System ( Site 1014), Detroit

52242

University of Iowa ( Site 1012), Iowa City

52621

Sheba Medical Center - Oncology Division ( Site 1501), Ramat Gan

54519

Institut De Cancerologie De Lorraine ( Site 1204), Vandœuvre-lès-Nancy

60637

University of Chicago ( Site 1013), Chicago

67200

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203), Strasbourg

75390

UTSW Medical Center ( Site 1003), Dallas

94158

University of California at San Francisco ( Site 1008), San Francisco

94800

Gustave Roussy ( Site 1202), Villejuif

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900), Bogotá

200001

Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905), Valledupar

230002

Oncomédica S.A.S ( Site 1904), Montería

760032

Fundación Valle del Lili ( Site 1901), Santiago de Cali

2520598

ONCOCENTRO APYS-ACEREY ( Site 2103), Viña del Mar

3525408

Rambam MC ( Site 1500), Haifa

4800827

James Lind Centro de Investigación del Cáncer ( Site 2108), Temuco

4810148

CIDO SpA-Oncology ( Site 2106), Temuco

4941492

Rabin Medical Center ( Site 1502), Petah Tikva

6423906

Sourasky Medical Center ( Site 1503), Tel Aviv

7500921

FALP-UIDO ( Site 2100), Santiago

7510032

Oncovida ( Site 2107), Santiago

8420383

Bradfordhill-Clinical Area ( Site 2101), Santiago

9112001

Hadassah Medical Center-Oncology ( Site 1504), Jerusalem

06510

Yale-New Haven Hospital-Yale Cancer Center ( Site 1011), New Haven

M5G 1Z5

Princess Margaret Cancer Centre ( Site 1101), Toronto

H3T 1E2

Jewish General Hospital ( Site 1100), Montreal

1066CX

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402), Amsterdam

3015 GD

Erasmus Medisch Centrum ( Site 2401), Rotterdam

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201), Bydgoszcz

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200, Warsaw

80-952

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202), Gdansk

05505

Asan Medical Center ( Site 1800), Songpagu

03722

Severance Hospital ( Site 1802), Seoul

06351

Samsung Medical Center ( Site 1801), Seoul

08035

Hospital Universitari Vall d Hebron ( Site 1300), Barcelona

SO16 6YD

Southampton General Hospital ( Site 1403), Southampton

G12 0YN

The Beatson West of Scotland Cancer Centre ( Site 1405), Glasgow

PR2 9HT

Royal Preston Hospital ( Site 1406), Preston

LE1 5WW

Leicester Royal Infirmary ( Site 1408), Leicester

EC1A 7BE

Barts Health NHS Trust ( Site 1401), London

EH4 2XU

Western General Hospital ( Site 1402), Edinburgh

CF14 2TL

Velindre Cancer Centre Hospital ( Site 1407), Cardiff

M20 4BX

The Christie NHS Foundation Trust ( Site 1400), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY