drugset / Trial / NCT04446117

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

NCT04446117

Phase 3 Active not recruiting 575 enrolled Exelixis Roche-Genentech · collabTakeda · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-10-19
Primary completion
2024-04-19
Completion
2026-10-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abiraterone acetate Small molecule 1000 mg Oral
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Cabozantinib Small molecule 40 mg Oral
Comparator Enzalutamide Other / unclassified 160 mg Oral
Comparator Prednisone Other / unclassified 5 mg Oral