Status:
ACTIVE_NOT_RECRUITING
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Arcus Biosciences, Inc.
Conditions:
Advanced Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ad...
Detailed Description
The primary purpose of this study is to determine the recommended Phase III dose (RP3D) of volrustomig and measure the efficacy and safety of volrustomig in combination with casdatifan compared with n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 29 2032
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT07000149
Start Date
July 28 2025
End Date
July 29 2032
Last Update
November 14 2025
Active Locations (33)
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1
Research Site
La Jolla, California, United States, 92037
2
Research Site
Aurora, Colorado, United States, 80045
3
Research Site
Boston, Massachusetts, United States, 02215
4
Research Site
New York, New York, United States, 10065