A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

Summary

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Timeline

Start

2020-02-06

Primary completion

2023-06-01

Completion

2024-06-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Nivolumab + Docetaxel + Prednisone vs Placebo + Docetaxel + Prednisone; p = 0.5901; NCT04100018 ↗

registry analysis (superiority test); Nivolumab + Docetaxel + Prednisone vs Placebo + Docetaxel + Prednisone; p = 0.3572; NCT04100018 ↗

paper Nivolumab plus docetaxel did not improve progression-free survival or overall survival versus placebo plus docetaxel in patients with ARPI-pretreated, chemotherapy-naive mCRPC. PMID 41449150 ↗

Publications

• Fizazi K, Saad F, Alonso-Gordoa T, Zurawski B, Barthelemy P, Voog E, Cutuli HJ, Buchler T, Ye D, Castellano D, Kwiatkowski M, Arslan C, Richardet M, Alifrangis C, Goh JC, Vianna K, Han W, Hatano K, Todenhofer T, Retz M, Srivastava A, Jin C, Gupta S, Trandafirescu G, Campos A, Lee CW, van Kooten Losio M, Subudhi SK. Nivolumab plus docetaxel versus placebo plus docetaxel for androgen receptor pathway inhibitor-pretreated and chemotherapy-naive metastatic castration-resistant prostate cancer (CheckMate 7DX): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):68-78. doi: 10.1016/S1470-2045(25)00566-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	—
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	—	—

Indications