Study on Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab for First-Line Treatment of Advanced Kidney Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07000149

Provider View

This clinical trial is comparing the effectiveness and safety of a new treatment, Volrustomig with or without Casdatifan, against the standard treatment of Nivolumab and Ipilimumab for patients with advanced clear cell renal cell carcinoma (ccRCC).

Patient Parameters

Program Overview

The study aims to find out if the new treatment, Volrustomig, alone or with Casdatifan, is safe and effective for treating advanced clear cell renal cell carcinoma (ccRCC) as a first-line treatment. It will compare this new treatment to the current standard treatment, which is a combination of Nivolumab and Ipilimumab.

Description

This study is divided into two parts:

In the first part (Phase Ib), participants will be randomly assigned to receive one of two different doses of Volrustomig combined with Casdatifan. This will help determine the best dose to use in the next phase.

In the second part (Phase III), participants will be randomly assigned to one of three groups: one group will receive the best dose of Volrustomig with Casdatifan, another group will receive Volrustomig alone, and the third group will receive the standard treatment of Nivolumab plus Ipilimumab. The goal is to see which treatment works best and is safest for patients with advanced kidney cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with kidney cancer that has a clear cell component.
  • The cancer is advanced, has spread, or has come back and has not been treated with systemic therapy before.
  • Have a Karnofsky Performance Status score of 70% or higher, indicating the ability to care for oneself and carry out normal activities.
  • Able to provide a suitable tumor sample for the study.
  • Have at least one tumor that can be accurately measured by scans, with specific size requirements.

Exclusion Criteria

  • Have a history of cancer spreading to the membranes covering the brain and spinal cord or spinal cord compression.
  • Have symptoms from cancer that has spread to the brain.
  • Have a history of severe chronic lung disease.
  • Have active or previously diagnosed autoimmune or inflammatory disorders.
  • Have received prior systemic therapy for advanced or metastatic kidney cancer.

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