Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Nabil Adra
- Study ID
- NCT02619253
- Phase
- PHASE1
- Status
- Completed
Conditions
- Renal Cell Carcinoma
- Urinary Bladder Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — DRUG
- Vorinostat — DRUG
Study Details
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)
Key Dates
- Start date
- Feb 23, 2016
- Status verified
- Sep 2024
- Primary completion
- Mar 28, 2023
- Completion
- Mar 28, 2023
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose Finding CohortEstimate the Recommended Phase 2 Dose (RP2D) in patients with advanced renal and urothelial cell carcinoma patients. Patients will be treated with oral vorinostat every day for 14 days, and with pembrolizumab at the fixed dose of 200 mg IV. Each cycle is every 21 days. Two dose levels of vorinostat will be tested in 2 patient cohorts according to the 3 + 3 standard design (100 and 200 mg).
- Experimental: Expansion CohortOnce the Expansion Test Dose is identified, the Dose Expansion Phase will be opened and the combination will be tested in patients with advanced renal cell or urothelial cell carcinoma. Forty-five patients with prior treatments will be enrolled in three expansion cohorts: 15 anti-PD1 naive renal and urothelial patients, 15 anti-PD1 resistant renal and urothelial patients (defined as patients with transient clinical response or without clinical response to prior immune-checkpoint inhibition), and 15 patients with androgen-sensitive or castration-resistant prostate cancer.
Primary Outcome Measure
Objective Response Rate (Percentage of Patients With Complete Response or Partial Response) [ Time Frame: Up to 4.5 years ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | - |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | - |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | - |
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