NCT07000149PHASE3ACTIVE_NOT_RECRUITING

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

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)

Sponsor: AstraZeneca + Arcus Biosciences, Inc.

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Interventions

Volrustomig, Casdatifan, Nivolumab, Ipilimumab

Enrollment

1,116 participants

Primary completion

Feb 2030

Study completion

Jul 2032

First posted

Jun 2025

Last updated

Mar 2026

Primary Endpoints (CT.gov)

Phase Ib: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Time frame: Approximately 39 months

Phase III: Progression-free Survival (PFS)

Time frame: Approximately 38 months

Phase III: Overall Survival (OS)

Time frame: Approximately 67 months

Secondary Endpoints

Phase Ib: Objective Response rate (ORR)

Phase Ib: Duration of Response (DoR)

Phase Ib: Progression-free Survival (PFS)

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically confirmed RCC with clear cell component. * Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting. * Karnofsky Performance Status ≥ 70%. * Provision of acceptable tumor sample. * At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. Exclusion Criteria: * History of leptomeningeal disease or spinal cord compression. * Symptomatic brain metastases. * Medical history of severe chronic obstructive pulmonary disease. * Active or prior documented autoimmune or inflammatory disorders. * Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov