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)

Part of paid clinical trials in Orange, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05562830
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zilovertamab vedotin — BIOLOGICAL
    Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles
  • Pembrolizumab — BIOLOGICAL
    Administered via IV infusion on Day 1 of each 6 week cycle.
  • MK-3120 — BIOLOGICAL
    Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.

Study Details

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.

Key Dates

Start date
Nov 16, 2022
Status verified
May 2026
Primary completion
Feb 26, 2029
Completion
Feb 26, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Zilovertamab vedotin
    Participants will receive zilovertamab vedotin 2mg/kg administered on Day 1 and Day 8 of each 3 week cycle (Q3W) until documented disease progression or any other discontinuation criterion is met.
  • Experimental: Arm B: Pembrolizumab and MK-3120
    Participants will receive MK-3120 up to 5mg/kg administered on Day 1, Day 15 and Day 29 of each 6 week cycle until documented disease progression or any other discontinuation criterion is met and 400mg pembrolizumab on Day 1 of each 6 week cycle for up to 17 cycles (up to \~2 years).

Primary Outcome Measure

Percentage of Participants Who Experienced At Least One Adverse Event (AE) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)OrangeCalifornia92868
Study Coordinator
714-509-2371
University of California San Francisco ( Site 1044)San FranciscoCalifornia94158
Study Coordinator
415-476-4616
Anschutz Cancer Pavilion ( Site 1017)AuroraColorado80045-
University of Chicago Medical Center ( Site 1037)ChicagoIllinois60637
Study Coordinator
855-702-8222
Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)IndianapolisIndiana46202
Study Coordinator
888-600-4822
Siteman Cancer Center ( Site 1038)St LouisMissouri63108
Study Coordinator
800-600-3606
Memorial Sloan Kettering Cancer Center ( Site 1031)New YorkNew York10065
Study Coordinator
646-888-4770
Cleveland Clinic-Taussig Cancer Center ( Site 1036)ClevelandOhio44195
Study Coordinator
216-445-7728
UPMC Hillman Cancer Center ( Site 1014)PittsburghPennsylvania15232
Study Coordinator
412-623-4759
Huntsman Cancer Institute ( Site 1041)Salt Lake CityUtah84112-5500
Study Coordinator
801-585-0155

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