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

NCT07000149 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1116

Last updated 2026-03-10

No results posted yet for this study

Summary

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).

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma

Interventions

DRUG

Volrustomig

Volrustomig will be administered as an intravenous (IV) infusion.

DRUG

Casdatifan

Casdatifan will be administered orally.

DRUG

Nivolumab

Nivolumab will be administered as an IV infusion.

DRUG

Ipilimumab

Ipilimumab will be administered as an IV infusion.

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2030-02-21
Completion
2032-07-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Georgia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07000149 on ClinicalTrials.gov