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A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
Sponsor: AstraZeneca
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1116
Start Date
2025-07-28
Completion Date
2032-07-29
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Casdatifan
Casdatifan will be administered orally.
Nivolumab
Nivolumab will be administered as an IV infusion.
Ipilimumab
Ipilimumab will be administered as an IV infusion.
Locations (32)
Research Site
La Jolla, California, United States
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Aurora, Colorado, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Nashville, Tennessee, United States
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Lubbock, Texas, United States
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East Melbourne, Australia
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Elizabeth Vale, Australia
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North Adelaide, Australia
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Syndey, Australia
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Beijing, China
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Guangzhou, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Xiamen, China
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Batumi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Busan, South Korea
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Seongnam-si, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Kaohsiung City, Taiwan
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Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan