Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

Summary

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

Timeline

Start

2021-12-13

Primary completion

2025-03-05

Completion

2027-07-16

Outcome

Met primary endpoint

registry analysis (superiority test); Pembrolizumab + Paclitaxel ± Bevacizumab vs Placebo + Paclitaxel ± Bevacizumab; p = 0.0022; Hazard Ratio (HR) 0.75 (95% CI 0.61 to 0.91); NCT05116189 ↗

registry analysis (superiority test); Pembrolizumab + Paclitaxel ± Bevacizumab vs Placebo + Paclitaxel ± Bevacizumab; p = 0.0001; Hazard Ratio (HR) 0.73 (0.95% CI 0.62 to 0.86); NCT05116189 ↗

Publications

• Colombo N, Zsiros E, Parma G, Rulli E, Sebastianelli A, Bidzinski M, Gallardo C, Matanes E, Hasegawa K, Kose F, Magallanes-Maciel M, Herbertson RA, Ananda S, Kroep JR, de Melo AC, Debruyne PR, Kim JW, Sehouli J, Pierre ME, Hietanen S, Zamagni C, Lu X, Monk BJ, Coleman RL, Peng X, Yamada K, Bogusz AM, De La Motte Rouge T, Wu X; ENGOT-ov65/KEYNOTE-B96 investigators. Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2026 Apr 18;407(10538):1525-1537. doi: 10.1016/S0140-6736(26)00602-1. Epub 2026 Apr 10.
• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	400 mg	Intravenous
Background	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications