Clinical Trial

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

Active, Not Recruiting Phase 1/2
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Summary
This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2017-05-30; most recent amendment 2026-05-20.
Status change: Recruiting → Active, Not Recruiting 2024-05-01
Status change: Not Yet Recruiting → Recruiting 2017-06-12
Trial Details
NCT Number NCT03172754
Lead Sponsor Fox Chase Cancer Center
Conditions Renal Cell Carcinoma
Enrollment 98 participants
Start Date 2017-06-12
Primary Completion 2026-11-06 (estimated)
Study Completion 2027-04-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-22