Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Status:
Recruiting
Trial end date:
2026-10-12
Target enrollment:
Participant gender:
Summary
This study is a randomized, open label, multicenter Phase II trial to evaluate the efficacy
and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and balstilimab (a
novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve patients with
metastatic ccRCC. The study will plan to enroll 120 eligible patients randomized in a 2:1
fashion to Arm A and Arm B. Patients in all IMDC Risk Groups are included. This study
utilizes a Simon's two stage design which is described in the protocol. Patients randomized
to Arm A will receive botensilimab in combination with balstilimab. Patients randomized to
Arm B will receive ipilimumab in combination with nivolumab. Study treatment on both arms
will continue until toxicity, disease progression or a maximum of 96 total weeks (12 weeks
induction, 84 weeks maintenance).