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

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.

Trial Details

NCT ID
NCT07011719
Phase
PHASE3
Sponsor
Arcus Biosciences, Inc.
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Casdatifan
  • Cabozantinib
  • Placebo
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
  • A Karnofsky Performance Status (KPS) score ≥ 80%
  • At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
  • Adequate organ and marrow function, ≤ 1 week prior to randomization.

For full eligibility, visit ClinicalTrials.gov.

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