NCT06483334 - A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 17, 2024

Primary Completion Date

July 28, 2028

Study Completion Date

July 28, 2028

Conditions

Metastatic Urothelial CarcinomaLocally Advanced Urothelial Carcinoma

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

IV infusion at different dose levels

BIOLOGICAL

Enfortumab Vedotin

IV infusion at different dose levels

BIOLOGICAL

Pembrolizumab

200 mg IV infusion

Trial Locations (25)

704

RECRUITING

National Cheng Kung University Hospital-Clinical Trial Center ( Site 4803), Tainan City

10029

RECRUITING

Icahn School of Medicine at Mount Sinai ( Site 4018), New York

20132

RECRUITING

Ospedale San Raffaele-Oncologia Medica ( Site 4403), Milan

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 4405), Milan

28040

RECRUITING

Hospital Clinico San Carlos ( Site 4765), Madrid

44195

RECRUITING

Cleveland Clinic-Taussig Cancer Center ( Site 4036), Cleveland

46202

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center ( Site 4011), Indianapolis

60637

RECRUITING

University of Chicago Medical Center ( Site 4037), Chicago

63108

RECRUITING

Siteman Cancer Center ( Site 4038), St Louis

69310

RECRUITING

Centre Hospitalier Lyon Sud ( Site 4606), Pierre-Bénite

80131

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 4406), Napoli

84112

RECRUITING

Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 4041), Salt Lake City

94158

RECRUITING

University of California San Francisco HDFCCC ( Site 4044), San Francisco

3109601

RECRUITING

Rambam Health Care Campus ( Site 4501), Haifa

4941492

RECRUITING

Rabin Medical Center-Oncology ( Site 4504), Petah Tikva

5265601

RECRUITING

Sheba Medical Center-ONCOLOGY ( Site 4503), Ramat Gan

02115

ACTIVE_NOT_RECRUITING

Dana-Farber Cancer Institute ( Site 4047), Boston

K1H 8L6

RECRUITING

The Ottawa Hospital - General Campus ( Site 4105), Ottawa

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre ( Site 4106), Toronto

1066 CX

RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 4302), Amsterdam

03722

RECRUITING

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4903), Seoul

05505

RECRUITING

Asan Medical Center-Department of Oncology ( Site 4901), Seoul

06351

RECRUITING

Samsung Medical Center ( Site 4902), Seoul

08035

RECRUITING

Hospital Universitari Vall d'Hebron-Oncology ( Site 4767), Barcelona

EC1A 7BE

RECRUITING

St Bartholomew s Hospital ( Site 4206), London

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY