OncRef

Clinical Trial: NCT07011719

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Arcus Biosciences, Inc.
Information Provided By:Arcus Biosciences, Inc.
Last Update Posted:2026-09-29

Study Overview

Brief Summary

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Official Title

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Conditions

Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma

Intervention / Treatment

  • Drug: Casdatifan
  • Drug: Cabozantinib
  • Drug: Placebo

Other Study ID Numbers

  • PEAK-1
  • 2024-515023-11-00

Start Date (Actual)

2025-09-08

Primary Completion Date (Estimated)

2028-04

Study Completion Date (Estimated)

2030-12

Enrollment (Estimated)

720

Study Type

Interventional

Phase

Phase 3