A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A

Summary

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

Locations (28)