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 for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the most recent regimen (either adjuvant monotherapy or first-line in combination with anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.

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
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311

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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