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

Treatment Options for Advanced Kidney Cancer

J
Jennifer King

Primary Investigator

Recruiting
18 years - 100 years
All
Phase 3
5 participants needed
3 Locations

Brief description of study

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.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Primary: To compare PFS of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients. 

Secondary: To compare OS of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients. To assess additional measures of clinical activity in all randomized patients. To assess the safety and tolerability of casdatifan or placebo in combination with cabozantinib in all patients treated. To evaluate disease-related symptoms based on patient-reported outcomes using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 Item Version (NFKSI-19) of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion 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, ≤ 72 hours prior to randomization.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.

Exclusion Criteria:

  • Received prior treatment with a HIF-2α inhibitor or cabozantinib.
  • Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
  • 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.
  • Uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure > 140/90 mm Hg on more than three antihypertensives
  • History of leptomeningeal disease or spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

This study investigates treatments for advanced clear cell renal cell carcinoma, a type of kidney cancer. The purpose of this study is to compare the effects of an investigational medication combined with cabozantinib versus a placebo combined with cabozantinib. Participants in this study have advanced or metastatic clear cell renal cell carcinoma that has progressed after previous immunotherapy treatments.

Participants will receive either the investigational medication with cabozantinib or a placebo with cabozantinib. The study will evaluate how long participants live without their cancer getting worse, as well as overall survival and the safety of the treatments. Patient-reported outcomes will also be assessed to understand the impact of symptoms related to the disease.

  • Who can participate: Adults with advanced or metastatic clear cell renal cell carcinoma may participate. They must not have been treated with HIF-2α inhibitors or cabozantinib. Participants need a Karnofsky Performance Status score of 80% or higher and adequate organ function.
  • Study details: Participants will be randomly assigned to receive either the investigational medication with cabozantinib or a placebo with cabozantinib. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 09 Apr 2026. Study ID: CTO-PEAK-1, 28475

Find a site

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the Study Team