A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC - eVOLVE-RCC02
Study identifier:D798NC00001
ClinicalTrials.gov identifier:NCT07000149
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
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)
Medical condition
Advanced Clear Cell Renal Cell Carcinoma
Phase
Phase 3
Healthy volunteers
No
Study drug
Volrustomig, Casdatifan, Nivolumab, Ipilimumab
Sex
All
Actual Enrollment
1116
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 28 Jul 2025
Estimated Primary Completion Date: 21 Feb 2030
Estimated Study Completion Date: 29 Jul 2032
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Arcus Biosciences, Inc
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1A (Volrustomig Dose 1 + Casdatifan) Participants will receive dose 1 of volrustomig in combination with casdatifan. | Drug: Volrustomig Volrustomig will be administered as an intravenous (IV) infusion. Other Name: MEDI5752 Drug: Casdatifan Casdatifan will be administered orally. Other Name: AB521 |
| Experimental: Arm 1B (Volrustomig Dose 2 + Casdatifan) Participants will receive dose 2 of volrustomig in combination with casdatifan. | Drug: Volrustomig Volrustomig will be administered as an intravenous (IV) infusion. Other Name: MEDI5752 Drug: Casdatifan Casdatifan will be administered orally. Other Name: AB521 |
| Experimental: Arm 3A (Volrustomig Dose X + Casdatifan) Participants will receive Volrustomig at the dose to be determined in the Phase Ib part of the study, in combination with casdatifan. | Drug: Volrustomig Volrustomig will be administered as an intravenous (IV) infusion. Other Name: MEDI5752 Drug: Casdatifan Casdatifan will be administered orally. Other Name: AB521 |
| Experimental: Arm 3B (Volrustomig Dose 1) Participants will receive dose 1 of volrustomig. | Drug: Volrustomig Volrustomig will be administered as an intravenous (IV) infusion. Other Name: MEDI5752 |
| Active Comparator: Arm 3C (Nivolumab + Ipilimumab) Participants will receive nivolumab plus ipilimumab as standard of care treatment. | Drug: Nivolumab Nivolumab will be administered as an IV infusion. Other Name: Opdivo Drug: Ipilimumab Ipilimumab will be administered as an IV infusion. Other Name: Yervoy |
