RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-09-08
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07011719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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.
  1. * Received prior treatment with a HIF-2α inhibitor or cabozantinib.
  2. * Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
  3. * Clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
  4. * Uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure \> 140/90 mm Hg on more than three antihypertensives
  5. * History of leptomeningeal disease or spinal cord compression.

Contacts and Locations

Study Contact

Medical Director
CONTACT
+1-510-462-3330
clinicaltrials@arcusbio.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Arcus Biosciences

Study Locations (Sites)

City of Hope - Phoenix Cancer Center
Goodyear, Arizona, 85338
United States
City Of Hope National Medical Center
Duarte, California, 91010
United States
Piedmont Cancer Institute OneOncology
Atlanta, Georgia, 30318
United States
City of Hope Cancer Center Atlanta
Newnan, Georgia, 30265
United States
City of Hope - Chicago Cancer Center
Zion, Illinois, 60099
United States

Collaborators and Investigators

Sponsor: Arcus Biosciences, Inc.

  • Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-08
Study Completion Date2030-12

Study Record Updates

Study Start Date2025-09-08
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • Casdatifan
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Advanced Clear Cell Renal Cell Carcinoma
  • Kidney Cancer
  • PEAK-1
  • AB521
  • ccRCC

Additional Relevant MeSH Terms

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