NCT07011719 · Arcus Biosciences, Inc.
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
What this study is about
The purpose of the study is to evaluate the time without the disease getting worse (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.
View original scientific 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.
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
Primary outcome measures
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Gilbert, Arizona
- Goodyear, Arizona
- Phoenix, Arizona
- Duarte, California
- La Jolla, California
- Los Angeles, California
- Sacramento, California
- San Diego, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Miami, Florida
And 27 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations