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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)
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).
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
La Jolla, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Lubbock, Texas, United States
Research Site
East Melbourne, Australia
Research Site
Elizabeth Vale, Australia
Research Site
North Adelaide, Australia
Start Date
July 28, 2025
Primary Completion Date
February 21, 2030
Completion Date
July 29, 2032
Last Updated
March 10, 2026
1,116
ESTIMATED participants
Volrustomig
DRUG
Casdatifan
DRUG
Nivolumab
DRUG
Ipilimumab
DRUG
Lead Sponsor
AstraZeneca
Collaborators
NCT07097935
NCT05361720
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05122546