Overview

Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma

Status:
Active, not recruiting

Trial end date:
2023-05-31

Target enrollment:

Participant gender:

Summary

Primary objective: To assess the early signals for anti-tumor activity (i.e. objective response rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients with advanced prostate, renal or urothelial cell carcinoma. Secondary objectives: (1) To evaluate the overall safety profile of pembrolizumab in combination with vorinostat; (2) To assess the safety and tolerability of pembrolizumab in combination with vorinostat in patients with advanced prostate, renal or urothelial cell carcinoma in order to select the recommended Phase 2 Dose (RP2D); (3) To characterize immune cell subsets, and miRs in tumor and/or blood.

Phase:

Phase 1

Details

Lead Sponsor:

Nabil Adra
Roberto Pili

Treatments:

Pembrolizumab
Vorinostat