Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorArcus Biosciences, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Casdatifan
- Cabozantinib
- Placebo
Treatment groups
720 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov