COMbination of Bipolar Androgen Therapy and Nivolumab

Summary

Single arm, multicenter, open-label Phase II study of the effects of parenteral testosterone in combination with nivolumab in men with metastatic castration-resistant prostate cancer who previously progressed on at least one novel androgen-receptor targeted therapy (i.e. Abiraterone acetate, Enzalutamide). Up to one taxane agent is permitted.

Timeline

Start

2018-09-05

Primary completion

2022-10-27

Completion

2023-01-06

Publications

• Markowski MC, Taplin ME, Aggarwal R, Sena LA, Wang H, Qi H, Lalji A, Sinibaldi V, Carducci MA, Paller CJ, Marshall CH, Eisenberger MA, Sanin DE, Yegnasubramanian S, Gomes-Alexandre C, Ozbek B, Jones T, De Marzo AM, Denmeade SR, Antonarakis ES. Bipolar androgen therapy plus nivolumab for patients with metastatic castration-resistant prostate cancer: the COMBAT phase II trial. Nat Commun. 2024 Jan 2;15(1):14. doi: 10.1038/s41467-023-44514-2.

Drugs

Indications