COMbination of Bipolar Androgen Therapy and Nivolumab

Phase 2 Completed 45 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bristol-Myers Squibb · collab

NaSingle-groupOpen-labelTreatment

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

Outcome

Met primary endpoint

paper The primary endpoint of a confirmed PSA50 response rate was met PMID 38167882 ↗

paper estimated at 40% (N = 18/45, 95% CI: 25.7-55.7%, P = 0.02 one-sided against the 25% null hypothesis). PMID 38167882 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Subject	Testosterone Cypionate	Small molecule	400 mg	Intramuscular