Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

December 17, 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 200 mg Q3W or 400 mg Q6W

BIOLOGICAL

MK-4830

Administered via IV infusion at a dose of 800 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

BIOLOGICAL

Favezelimab/Pembrolizumab

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

Trial Locations (51)

1023

Auckland City Hospital ( Site 3700), Auckland

1122

Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 4301), Budapest

2148

Blacktown Hospital ( Site 3601), Blacktown

2217

St George Hospital ( Site 3602), Kogarah

3084

Austin Health ( Site 3600), Melbourne

4029

Royal Brisbane and Women's Hospital ( Site 3603), Herston

10016

Laura and Isaac Perlmutter Cancer Center ( Site 3016), New York

10065

Memorial Sloan Kettering Cancer Center ( Site 3002), New York

15232

UPMC Cancer Center/Hillman Cancer Center ( Site 3017), Pittsburgh

27710

Duke Cancer Institute ( Site 3015), Durham

28034

Hospital Universitario Ramon y Cajal ( Site 3301), Madrid

31059

Institut Claudius Regaud ( Site 3200), Toulouse

37232

Vanderbilt University Medical Center ( Site 3004), Nashville

48202

Henry Ford Health System ( Site 3014), Detroit

52242

University of Iowa ( Site 3012), Iowa City

52621

Sheba Medical Center - Oncology Division ( Site 3501), Ramat Gan

54519

Institut De Cancerologie De Lorraine ( Site 3204), Vandœuvre-lès-Nancy

60637

University of Chicago ( Site 3013), Chicago

67200

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 3203), Strasbourg

75390

UTSW Medical Center ( Site 3003), Dallas

94158

University of California at San Francisco ( Site 3008), San Francisco

94800

Gustave Roussy ( Site 3202), Villejuif

2520598

ONCOCENTRO APYS-ACEREY ( Site 4103), Viña del Mar

3109601

Rambam Health Care Campus-Oncology Division ( Site 3500), Haifa

4800827

James Lind Centro de Investigacion del Cancer ( Site 4108), Temuco

4810148

CIDO SpA-Oncology ( Site 4106), Temuco

4941492

Rabin Medical Center ( Site 3502), Petah Tikva

6423906

Sourasky Medical Center ( Site 3503), Tel Aviv

7500921

FALP-UIDO ( Site 4100), Santiago

8420383

Bradfordhill-Clinical Area ( Site 4101), Santiago

9112001

Hadassah Medical Center-Oncology ( Site 3504), Jerusalem

06510

Yale-New Haven Hospital-Yale Cancer Center ( Site 3011), New Haven

M5G 1Z5

Princess Margaret Cancer Centre ( Site 3101), Toronto

H3T 1E2

Jewish General Hospital ( Site 3100), Montreal

1066 CX

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 4402), Amsterdam

3015 GD

Erasmus Medisch Centrum ( Site 4401), Rotterdam

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 4201), Bydgoszcz

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4200), Warsaw

80-952

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 4202), Gdansk

05505

Asan Medical Center ( Site 3800), Songpagu

03722

Severance Hospital ( Site 3802), Seoul

06351

Samsung Medical Center ( Site 3801), Seoul

08035

Hospital Universitari Vall d Hebron ( Site 3300), Barcelona

SO16 6YD

Southampton General Hospital ( Site 3403), Southampton

G12 0YN

The Beatson West of Scotland Cancer Centre ( Site 3405), Glasgow

PR2 9HT

Royal Preston Hospital ( Site 3406), Preston

LE1 5WW

Leicester Royal Infirmary ( Site 3408), Leicester

EC1A 7BE

Barts Health NHS Trust ( Site 3401), London

EH4 2XU

Western General Hospital ( Site 3402), Edinburgh

CF14 2TL

Velindre Cancer Centre Hospital ( Site 3407), Cardiff

M20 4BX

The Christie NHS Foundation Trust ( Site 3400), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY