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

NCT07011719 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Metastatic Clear Cell Renal Cell Carcinoma
  • Advanced Clear Cell Renal Cell Carcinoma

Interventions

DRUG

Casdatifan

Administered as specified in the treatment arm

DRUG

Cabozantinib

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Arcus Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2028-04-30
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011719 on ClinicalTrials.gov