A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
NCT ID: NCT07000149
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1116 participants
INTERVENTIONAL
2025-07-28
2032-07-29
Brief Summary
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Detailed Description
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The study comprises of 2 parts -
In Phase 1b part of the study, participants will be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.
In Phase III part of the study, participants will be randomized in 1:1:1 to receive either Volrustomig (at the dose to be determined in the Phase Ib) in combination with casdatifan, volrustomig monotherapy or standard of care (nivolumab plus ipilimumab).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1A (Volrustomig Dose 1 + Casdatifan)
Participants will receive dose 1 of volrustomig in combination with casdatifan.
Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Casdatifan
Casdatifan will be administered orally.
Arm 1B (Volrustomig Dose 2 + Casdatifan)
Participants will receive dose 2 of volrustomig in combination with casdatifan.
Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Casdatifan
Casdatifan will be administered orally.
Arm 3A (Volrustomig Dose X + Casdatifan)
Participants will receive Volrustomig at the dose to be determined in the Phase Ib part of the study, in combination with casdatifan.
Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Casdatifan
Casdatifan will be administered orally.
Arm 3B (Volrustomig Dose 1)
Participants will receive dose 1 of volrustomig.
Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Arm 3C (Nivolumab + Ipilimumab)
Participants will receive nivolumab plus ipilimumab as standard of care treatment.
Nivolumab
Nivolumab will be administered as an IV infusion.
Ipilimumab
Ipilimumab will be administered as an IV infusion.
Interventions
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Nivolumab
Nivolumab will be administered as an IV infusion.
Ipilimumab
Ipilimumab will be administered as an IV infusion.
Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Casdatifan
Casdatifan will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Symptomatic brain metastases.
* Medical history of severe chronic obstructive pulmonary disease.
* Active or prior documented autoimmune or inflammatory disorders.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
La Jolla, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Lubbock, Texas, United States
Research Site
East Melbourne, , Australia
Research Site
Elizabeth Vale, , Australia
Research Site
North Adelaide, , Australia
Research Site
Syndey, , Australia
Research Site
Beijing, , China
Research Site
Guangzhou, , China
Research Site
Nanjing, , China
Research Site
Nanning, , China
Research Site
Shanghai, , China
Research Site
Xiamen, , China
Research Site
Batumi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Busan, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Countries
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Other Identifiers
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2024-519865-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
D798NC00001
Identifier Type: -
Identifier Source: org_study_id
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