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)
Status: Active_not_recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Research Site
La Jolla
Colorado
Research Site
Aurora
Massachusetts
Research Site
Boston
New York
Research Site
New York
Ohio
Research Site
Cleveland
Tennessee
Research Site
Nashville
Texas
Research Site
Lubbock
Other Locations
Australia
Research Site
East Melbourne
Research Site
Elizabeth Vale
Research Site
Nedlands
Research Site
North Adelaide
Research Site
Syndey
China
Research Site
Beijing
Research Site
Guangzhou
Research Site
Nanjing
Research Site
Nanning
Research Site
Shanghai
Research Site
Xiamen
Georgia
Research Site
Batumi
Research Site
Tbilisi
Research Site
Tbilisi
Research Site
Tbilisi
Republic of Korea
Research Site
Busan
Research Site
Seongnam-si
Research Site
Seongnam-si
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Taiwan
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Taichung
Research Site
Tainan
Time Frame
Start Date:2025-07-28
Completion Date:2032-07-29
Participants
Target number of participants:1116
Treatments
Experimental: Arm 1A (Volrustomig Dose 1 + Casdatifan)
Participants will receive dose 1 of volrustomig in combination with casdatifan.
Experimental: Arm 1B (Volrustomig Dose 2 + Casdatifan)
Participants will receive dose 2 of volrustomig in combination with casdatifan.
Experimental: 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.
Experimental: Arm 3B (Volrustomig Dose 1)
Participants will receive dose 1 of volrustomig.
Active_comparator: Arm 3C (Nivolumab + Ipilimumab)
Participants will receive nivolumab plus ipilimumab as standard of care treatment.