A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

June 23, 2023

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Metastatic Urothelial CarcinomaUrothelial Neoplasms
Interventions
BIOLOGICAL

Coformulated favezelimab/pembrolizumab

Coformulated favezelimab/pembrolizumab (800 mg/200 mg) IV infusion

BIOLOGICAL

Coformulated vibostolimab/pembrolizumab

Coformulated vibostolimab/pembrolizumab (200 mg/200 mg) IV infusion

COMBINATION_PRODUCT

EV

1.25 mg/kg IV infusion

BIOLOGICAL

Pembrolizumab

200 mg IV infusion

Trial Locations (47)

704

National Cheng Kung University Hospital-Clinical Trial Center ( Site 3803), Tainan City

3084

Austin Health-Cancer Clinical Trials Centre ( Site 3950), Heidelberg

4029

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 3951), Brisbane

10002

National Taiwan University Hospital-Oncology ( Site 3801), Taipei

10029

Icahn School of Medicine at Mount Sinai ( Site 3018), New York

10065

Memorial Sloan Kettering Cancer Center ( Site 3031), New York

15232

UPMC Hillman Cancer Center ( Site 3014), Pittsburgh

20132

Ospedale San Raffaele-Oncologia Medica ( Site 3403), Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3405), Milan

21079

Centre Georges François Leclerc-Centre de recherche clinique ( Site 3608), Dijon

27710

Duke Cancer Institute ( Site 3027), Durham

28040

Hospital Clinico San Carlos ( Site 3765), Madrid

30322

Emory University School of Medicine ( Site 3043), Atlanta

31059

Oncopole Claudius Regaud ( Site 3610), Toulouse

33075

CHU de Bordeaux Hop St ANDRE ( Site 3607), Bordeaux

44195

Cleveland Clinic-Taussig Cancer Center ( Site 3036), Cleveland

46202

Indiana University Melvin and Bren Simon Cancer Center ( Site 3011), Indianapolis

63108

Siteman Cancer Center ( Site 3038), St Louis

69310

centre hospitalier lyon sud ( Site 3606), Pierre-Bénite

75015

Hôpital Européen Georges Pompidou ( Site 3605), Paris

80045

Anschutz Cancer Pavilion ( Site 3017), Aurora

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3406), Napoli

83301

Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 3802), Kaohsiung City

84112

Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041), Salt Lake City

92868

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045), Orange

94158

UCSF Medical Center at Mission Bay ( Site 3044), San Francisco

1240000

Bradford Hill Norte ( Site 3152), Antofagasta

2520598

ONCOCENTRO APYS-ACEREY ( Site 3158), Viña del Mar

3109601

Rambam Health Care Campus-Oncology Division ( Site 3501), Haifa

4941492

Rabin Medical Center-Oncology ( Site 3504), Petah Tikva

5265601

Sheba Medical Center-ONCOLOGY ( Site 3503), Ramat Gan

7500921

FALP-UIDO ( Site 3151), Santiago

8420383

Bradfordhill-Clinical Area ( Site 3155), Santiago

92093-0698

Moores Cancer Center ( Site 3028), La Jolla

02115

Dana-Farber Cancer Institute ( Site 3047), Boston

K1H 8L6

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105), Ottawa

M4N 3M5

Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 3106), Toronto

6229 HX

Maastricht UMC+ ( Site 3304), Maastricht

1066 CX

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 3302), Amsterdam

3015 GD

Erasmus Medisch Centrum-Medical Oncology ( Site 3303), Rotterdam

03722

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3903), Seoul

05505

Asan Medical Center-Department of Oncology ( Site 3901), Seoul

06351

Samsung Medical Center ( Site 3902), Seoul

08035

Hospital Universitari Vall d'Hebron ( Site 3767), Barcelona

EC1A 7BE

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3206), London

SW3 6JJ

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 3201), London

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY