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A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC

NCT07000149

Active Not RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Advanced Clear Cell Renal Cell Carcinoma

Interventions: Volrustomig, Casdatifan

Countries: Australia, South Korea

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). The Phase III part of the study will no longer be conducted.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (3)

Elizabeth Vale, Australia
Busan, South Korea
Seoul, South Korea