CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 575 enrolled
Drug / intervention
Cabozantinib +4 moredrug
Likely dose
Cabozantinib 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04446117
NCT04446117Phase 3Active
CompareCT.gov

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

Exelixis·interventional·Posted Jun 24, 2020·Updated Dec 18, 2025

In Brief

A Phase 3 clinical trial evaluating Cabozantinib, Atezolizumab, and 3 other interventions for Metastatic Prostate Cancer and Prostate Adenocarcinoma. Active but no longer recruiting, targeting 575 participants across 280 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Prostate Cancer, Prostate Adenocarcinoma
CountriesArgentina, 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, United States
CollaboratorsRoche-Genentech, Takeda

Timeline

Phase 3Active
202120222023202420252026
First PostedJun 24, 2020
Enrollment StartOct 19, 2020
Primary CompletionApr 19, 2024
Study CompletionOct 16, 2026
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.0 years ago

Interventions

Cabozantinibdrug

Supplied as 20-mg tablets; administered orally daily at 40mg

Atezolizumabdrug

Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)

Abiraterone Acetatedrug

Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid

Enzalutamidedrug

Supplied as 40 mg capsules; administered orally daily at 160mg

Prednisonedrug

Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily