Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan Rogel Cancer Center
- Study ID
- NCT03562507
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Renal Cell Carcinoma, Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ESK981 — DRUGESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles
- Nivolumab — DRUG480 mg/dose IV, Day 1 of each 28-day cycle
Study Details
The objective of the trial is to determine the clinical efficacy of ESK981 in combination with nivolumab therapy in patients with metastatic renal cell carcinoma (RCC).
Key Dates
- Start date
- Apr 11, 2019
- Status verified
- May 2024
- Primary completion
- Oct 18, 2022
- Completion
- Oct 18, 2022
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ESK981 MonotherapyESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles
- Experimental: ESK981 and NivolumabESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles Nivolumab: 480 mg/dose IV, Day 1 of each 28-day cycle
Primary Outcome Measure
1. The Percentage of Patients That Respond to Treatment With the Combination of ESK981 Monotherapy and Nivolumab Therapy (Cohort B). [ Time Frame: Up to 24 months after last dose of study treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | - |