Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer
Status:
Completed
Trial end date:
2020-06-23
Target enrollment:
Participant gender:
Summary
This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High
Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days
apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in
combination with Nivolumab.
Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the
anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate
that the combination of the two therapies would result in an increase in the overall response
rate, complete response rate, and improved survival outcomes compared to either of the
individual therapies.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center