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

NCT04446117 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2025-12-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Roche-Genentech

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • Exelixis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2024-04-19
Completion
2026-10-16
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446117 on ClinicalTrials.gov