Pembrolizumab/placebo plus paclitaxel with or without bevacizumab for ovarian cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65)
IRAS ID
1004238
Contact name
Agata Bogusz
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc
Eudract number
2020-005027-37
Clinicaltrials.gov Identifier
Research summary
Ovarian cancer (OC) is the 20th most common cancer but is the 8th primary cause of cancer related deaths in women. The survival rate for 5 years following diagnosis is approximately 48% as OC is typically diagnosed in advanced stages.
Treatment depends on the type and stage of the OC plus the patient medical history. Most patients have surgery and chemotherapy.
If the OC returns the patient has ‘Recurrent OC’. Recurrent OC is divided into two groups; 'platinum-sensitive OC' and 'platinum-resistant OC' (PROC). This clinical trial aims to treat PROC (where OC has returned after >6 months).
This trial will compare pembrolizumab plus paclitaxel, with or without bevacizumab, against placebo plus paclitaxel, with or without bevacizumab. Paclitaxel and bevacizumab are standard treatments for OC. Pembrolizumab is experimental, but approved for treating various cancers. It has not been approved for OC. Paclitaxel and bevacizumab are approved for OC.
The study is randomized and ‘double blind’ (neither the patient nor site doctor will know the allocated treatment).
• Test the safety of pembrolizumab plus paclitaxel, with or without bevacizumab
• See how well pembrolizumab plus paclitaxel, with or without bevacizumab works to control OC, compared to placebo plus paclitaxel, with or without bevacizumab.
• See if participants who get pembrolizumab plus paclitaxel, with or without bevacizumab, have a better quality of life compared to those who get placebo plus paclitaxel, with or without bevacizumab.
Each patient will be in the study for approximately 2 years and followed up afterwards for another 2 years. Visits will be approximately; every 3 weeks on treatment, 9-12 weeks in follow up and every 12 weeks in long term follow up.
The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), and will take place at 8 study sites in the UK.REC name
Wales REC 2
REC reference
21/WA/0358
Date of REC Opinion
23 Dec 2021
REC opinion
Further Information Favourable Opinion