A Phase 3 interventional study of Casdatifan and Cabozantinib in Metastatic Clear Cell Renal Cell Carcinoma and Advanced Clear Cell Renal Cell Carcinoma, sponsored by Arcus Biosciences, Inc.. Recruiting at 183 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Arcus Biosciences, Inc. · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Casdatifan and cabozantinib taken orally
Drug: Casdatifan · Drug: Cabozantinib
Placebo and cabozantinib taken orally
Drug: Cabozantinib · Drug: Placebo
Administered as specified in the treatment arm
Also known as: AB521
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
Overall Survival (OS)
Time frame: up to approximately 64 months
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
Disease Control Rate (DCR) by Blinded Independent Central Review (BICR)
Time frame: up to approximately 33 months
The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs)
Time frame: up to approximately 33 months
Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score.
Time frame: up to approximately 33 months
Showing the first 100 of 183 sites across 17 countries.
Plan to share: Yes — Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Supporting information: Study protocol, Sap, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Clear-cell metastatic renal cell carcinoma→
Arcus Biosciences, Inc.