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

Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Kidney Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07011719
Protocol IDs
PEAK-1 (primary)
NCI-2025-05062
2024-515023-11-00
Study Sponsor
Arcus Biosciences, Inc.

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.

Eligibility

  1. Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
  2. A Karnofsky Performance Status (KPS) score = 80%
  3. At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
  4. Adequate organ and marrow function, = 72 hours prior to randomization.
  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.

Treatment Sites in Georgia

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.