NCT04446117

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

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 575 (actual)
• Sponsor: Exelixis · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone, apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate cancer (mCSPC), non-metastatic CRPC (M0 CRPC), or mCRPC, and who have measurable extrapelvic disease. The multiple primary efficacy endpoints comparing the experimental arm and control arm are Duration of Progression Free Survival (PFS) per RECIST 1.1 by Blinded Independent Radiology Committee (BIRC) and Duration of Overall Survival (OS). The secondary efficacy endpoint is Objective Response Rate (ORR) per RECIST 1.1 per BIRC.

Conditions

• Metastatic Prostate Cancer
• Prostate Adenocarcinoma

Interventions

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

Timeline

• Start date: 2020-10-19
• Primary completion: 2024-04-19
• Completion: 2026-10-16
• First posted: 2020-06-24
• Last updated: 2025-12-18
• Results posted: 2025-12-18

Locations

280 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study