A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
eVOLVE-RCC02
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)
2 other identifiers
interventional
1,116
6 countries
32
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 advanced clear cell renal cell carcinoma (ccRCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2025
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 2, 2025
CompletedStudy Start
First participant enrolled
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 29, 2032
March 10, 2026
March 1, 2026
4.6 years
May 23, 2025
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase Ib: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants who received at least one dose of study treatment will be assessed.
Approximately 39 months
Phase III: Progression-free Survival (PFS)
The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).
Approximately 38 months
Phase III: Overall Survival (OS)
The OS is defined as the time from randomization until the date of death due to any cause.
Approximately 67 months
Secondary Outcomes (13)
Phase Ib: Objective Response rate (ORR)
Approximately 39 months
Phase Ib: Duration of Response (DoR)
Approximately 39 months
Phase Ib: Progression-free Survival (PFS)
Approximately 39 months
Phase Ib: Disease Control Rate (DCR)
Approximately 39 months
Phase Ib: Volrustomig concentration in serum
Up to 27 months
- +8 more secondary outcomes
Study Arms (5)
Arm 1A (Volrustomig Dose 1 + Casdatifan)
EXPERIMENTALParticipants will receive dose 1 of volrustomig in combination with casdatifan.
Arm 1B (Volrustomig Dose 2 + Casdatifan)
EXPERIMENTALParticipants will receive dose 2 of volrustomig in combination with casdatifan.
Arm 3A (Volrustomig Dose X + Casdatifan)
EXPERIMENTALParticipants will receive Volrustomig at the dose to be determined in the Phase Ib part of the study, in combination with casdatifan.
Arm 3B (Volrustomig Dose 1)
EXPERIMENTALParticipants will receive dose 1 of volrustomig.
Arm 3C (Nivolumab + Ipilimumab)
ACTIVE COMPARATORParticipants will receive nivolumab plus ipilimumab as standard of care treatment.
Interventions
Volrustomig will be administered as an intravenous (IV) infusion.
Casdatifan will be administered orally.
Nivolumab will be administered as an IV infusion.
Ipilimumab will be administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Arcus Biosciences, Inc.collaborator
Study Sites (32)
Research Site
La Jolla, California, 92037, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
New York, New York, 10065, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Lubbock, Texas, 79430, United States
Research Site
East Melbourne, 3002, Australia
Research Site
Elizabeth Vale, 5112, Australia
Research Site
North Adelaide, 5000, Australia
Research Site
Syndey, 4032, Australia
Research Site
Beijing, 100142, China
Research Site
Guangzhou, 510060, China
Research Site
Nanjing, 2100008, China
Research Site
Nanning, 530021, China
Research Site
Shanghai, 200032, China
Research Site
Xiamen, 361003, China
Research Site
Batumi, 6010, Georgia
Research Site
Tbilisi, 0112, Georgia
Research Site
Tbilisi, 0114, Georgia
Research Site
Tbilisi, 0186, Georgia
Research Site
Busan, 48108, South Korea
Research Site
Seongnam-si, 13496, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Kaohsiung City, 833401, Taiwan
Research Site
Taichung, 404327, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 704, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 2, 2025
Study Start
July 28, 2025
Primary Completion (Estimated)
February 21, 2030
Study Completion (Estimated)
July 29, 2032
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.