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

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT07000149
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Volrustomig — DRUG
    Volrustomig will be administered as an intravenous (IV) infusion.
  • Casdatifan — DRUG
    Casdatifan will be administered orally.
  • Nivolumab — DRUG
    Nivolumab will be administered as an IV infusion.
  • Ipilimumab — DRUG
    Ipilimumab will be administered as an IV infusion.

Study Details

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).

Key Dates

Start date
Jul 28, 2025
Status verified
Mar 2026
Primary completion
Feb 21, 2030
Completion
Jul 29, 2032

Study Design

Enrollment
1,116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1A (Volrustomig Dose 1 + Casdatifan)
    Participants will receive dose 1 of volrustomig in combination with casdatifan.
  • Experimental: Arm 1B (Volrustomig Dose 2 + Casdatifan)
    Participants will receive dose 2 of volrustomig in combination with casdatifan.
  • 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.
  • Experimental: Arm 3B (Volrustomig Dose 1)
    Participants will receive dose 1 of volrustomig.
  • Active Comparator: Arm 3C (Nivolumab + Ipilimumab)
    Participants will receive nivolumab plus ipilimumab as standard of care treatment.

Primary Outcome Measure

Phase Ib: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Approximately 39 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92037-
Research SiteAuroraColorado80045-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10065-
Research SiteClevelandOhio44106-
Research SiteNashvilleTennessee37232-
Research SiteLubbockTexas79430-

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