A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 16, 2022

Primary Completion Date

June 20, 2028

Study Completion Date

June 20, 2028

Conditions
Urothelial Carcinoma
Interventions
BIOLOGICAL

Zilovertamab vedotin

Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles

BIOLOGICAL

Pembrolizumab

Administered via IV infusion on Day 1 of each 6 week cycle.

BIOLOGICAL

MK-3120

Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.

Trial Locations (18)

2100

Rigshospitalet-Dept. of Oncology ( Site 1701), Copenhagen

4029

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 1952), Brisbane

15232

UPMC Hillman Cancer Center ( Site 1014), Pittsburgh

28040

Hospital Clinico San Carlos ( Site 1765), Madrid

44195

Cleveland Clinic-Taussig Cancer Center ( Site 1036), Cleveland

46202

Indiana University Melvin and Bren Simon Cancer Center ( Site 1011), Indianapolis

63108

Siteman Cancer Center ( Site 1038), St Louis

80045

Anschutz Cancer Pavilion ( Site 1017), Aurora

92868

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045), Orange

3109601

Rambam Health Care Campus-Oncology ( Site 1501), Haifa

4941492

Rabin Medical Center-Oncology ( Site 1504), Petah Tikva

5265601

Sheba Medical Center-ONCOLOGY ( Site 1503), Ramat Gan

7500921

FALP-UIDO ( Site 1151), Santiago

8420383

Bradford Hill ( Site 1155), Santiago

03722

Severance Hospital, Yonsei University Health System ( Site 1903), Seoul

05505

Asan Medical Center ( Site 1901), Seoul

06351

Samsung Medical Center ( Site 1902), Seoul

08035

Hospital Universitari Vall d'Hebron ( Site 1767), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY