Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Conditions

• Metastatic Prostate Cancer
• Prostate Adenocarcinoma

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Supplied as 20-mg tablets; administered orally daily at 40mg
• Atezolizumab — DRUG
  Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
• Abiraterone Acetate — DRUG
  Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
• Enzalutamide — DRUG
  Supplied as 40 mg capsules; administered orally daily at 160mg
• Prednisone — DRUG
  Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily

Study Details

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

Key Dates

Start date

Oct 19, 2020

Status verified

Dec 2025

Primary completion

Apr 19, 2024

Completion

Oct 16, 2026

Study Design

Enrollment

575 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm
  Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w
• Active Comparator: Control Arm
  Subjects with mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization

Primary Outcome Measure

Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC) [ Time Frame: Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 months) ]

Locations (36)

Related coverage on Hipa.ai

• Atezolizumab/Cabozantinib Combo Improves PFS in mCRPC Trial
  Atezolizumab · Dec 18, 2025 · ClinicalTrials.gov

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