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

Phase 1Active Not RecruitingNCT07000149

AstraZeneca9 enrolled

Overview

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.

The primary purpose of this study is to measure the efficacy and safety of volrustomig in combination with casdatifan in participants with advanced ccRCC (as 1L treatment). The study was planned to comprise of 2 parts - Phase Ib and Phase III. In Phase 1b part of the study, participants are planned to be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan. The Phase III part of the study will no longer be conducted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Interventions

VolrustomigDRUG

Volrustomig will be administered as an intravenous (IV) infusion.

CasdatifanDRUG

Casdatifan will be administered orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Research Site

Elizabeth Vale, Australia

Research Site

Busan, South Korea

Research Site

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Up to Day 90 (+7) post last dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.