Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
The purpose of this study is to evaluate the progression-free survival of treatment with casdatifan targeted therapy versus placebo, when each is given in combination with another targeted therapy called cabozantinib.
You may be eligible for this study if you have unresectable, locally advanced or metastatic renal cell carcinoma with a primary clear cell component. You should have experienced disease progression on or after prior treatment with an anti-PD-1 or anti-PD-L1 immunotherapy.
Eligible participants will be randomly allocated (by chance) to one of two treatment arms:
- Arm A: Casdatifan and cabozantinib, both taken orally.
- Arm B: Placebo and cabozantinib, both taken orally.
Conditions
This trial is treating people with unresectable, locally advanced or metastatic renal cell carcinoma with a primary clear cell component
Eligibility
Inclusion
- 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.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
Exclusion
- 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.
- Ongoing 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, defined as a sustained blood pressure > 150 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment.
- History of leptomeningeal disease or spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
Arcus Biosciences, Inc.
Scientific 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
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