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.
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.
Supplied as 20-mg tablets; administered orally daily at 40mg
Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
Supplied as 40 mg capsules; administered orally daily at 160mg
Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Pergamino, Buenos Aires, Argentina
Córdoba, Córdoba Province, Argentina
Viedma, Río Negro Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Buenos Aires, Argentina
Caba, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
La Rioja, Argentina
San Juan, Argentina
San Salvador de Jujuy, Argentina