NCT05928806

Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

Phase 2 Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Michael B. Atkins, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Botensilimab	Botensilimab 75mg IV
DRUG	Balstilimab	Balstilimab 450mg IV
DRUG	Ipilimumab	Ipilimumab 1mg/kg IV
DRUG	Nivolumab	Nivolumab at induction: 3mg/kg IV Nivolumab at maintenance: 480mg IV

Timeline

• Start date: 2023-09-25
• Primary completion: 2026-11-10
• Completion: 2027-11-10
• First posted: 2023-07-03
• Last updated: 2026-02-11

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study