NCT05501054

Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of ciforadenant, ipilimumab, and nivolumab can help to control advanced renal cell carcinoma

Detailed description

Primary Objectives: * To determine the safety and tolerability of ipilimumab, nivolumab, and ciforadenant in patients with untreated advanced renal cell carcinoma (RCC). * To assess the depth of responsein patients with untreated advanced renal cell carcinoma treated with ipilimumab, nivolumab, and ciforadenant. Secondary Objectives: • To estimate the objective response rate (ORR), duration of response (DOR) progression free survival (PFS), progressive disease (PD) rate, and irAE rate of ipilimumab, niovlumab, and Ciforadenant combination in untreated advanced RCC. Exploratory Objectives: • To assess association of gene expression signatures and pharmacodynamic parameters with outcome.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	Given by IV (vein)
DRUG	Nivolumab	Given by IV (vein)
DRUG	Ciforadenant	Given by PO

Timeline

• Start date: 2023-02-09
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-08-15
• Last updated: 2026-01-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study