NCT07000149

A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC

A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,116 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).

Detailed description

The primary purpose of this study is to determine the recommended Phase III dose (RP3D) of volrustomig and measure the efficacy and safety of volrustomig in combination with casdatifan compared with nivolumab plus ipilimumab in participants with advanced ccRCC (as 1L treatment). The study comprises of 2 parts - In Phase 1b part of the study, participants will be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan. In Phase III part of the study, participants will be randomized in 1:1:1 to receive either Volrustomig (at the dose to be determined in the Phase Ib) in combination with casdatifan, volrustomig monotherapy or standard of care (nivolumab plus ipilimumab).

Conditions

• Advanced Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Volrustomig	Volrustomig will be administered as an intravenous (IV) infusion.
DRUG	Casdatifan	Casdatifan will be administered orally.
DRUG	Nivolumab	Nivolumab will be administered as an IV infusion.
DRUG	Ipilimumab	Ipilimumab will be administered as an IV infusion.

Timeline

• Start date: 2025-07-28
• Primary completion: 2030-02-21
• Completion: 2032-07-29
• First posted: 2025-06-02
• Last updated: 2026-03-10

Locations

32 sites across 6 countries: United States, Australia, China, Georgia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study