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).
Additional locations may be listed on ClinicalTrials.gov for NCT07000149.
See trial information on ClinicalTrials.gov for a list of participating sites.
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).
Lead OrganizationAstraZeneca Pharmaceuticals LP
