This phase III trial is evaluating whether immunotherapy (pembrolizumab) versus placebo, combined with chemotherapy (paclitaxel), with or without targeted therapy (bevacizumab), is more effective in people with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
This trial is treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific 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)
Commercial Sponsor
Merck
Summary
Eligible participants will be randomised into either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive pembrolizumab plus paclitaxel, with or without bevacizumab. Pembrolizumab (400mg) will be administered via intravenous infusion (IV) for 18 6-week cycles. Paclitaxel (80mg/m^2) will be administered via IV on Days 1, 8 and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab (10mg/kg) via IV of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. In the Placebo Comparator Arm, placebo plus paclitaxel, with or without bevacizumab. A placebo will be administered via IV for 18 6-week cycles. Paclitaxel (80mg/m^2) will be administered via IV on Days 1, 8 and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) after Sponsor consultation. Participants may also receive bevacizumab (10mg/kg) via IV of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
Recruiting Hospitals Read More