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

Sponsor
AstraZeneca
Study ID
NCT07000149
Phase
PHASE1
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.

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). The Phase III part of the study will no longer be conducted.

Key Dates

First listed
Jun 2, 2025
Start date
Jul 28, 2025
Status verified
Jul 2026
Primary completion
Jan 29, 2027
Completion
Jan 29, 2027

Study Design

Enrollment
9 participants (actual)
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.

Primary Outcome Measure

Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Day 90 (+7) post last dose ]

Related Studies