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

NCT05116189 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2026-03-09

Study results available
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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.

Conditions

  • Ovarian Cancer
  • Carcinoma, Ovarian Epithelial
  • Fallopian Tube Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Bevacizumab

IV infusion

OTHER

Placebo for pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2025-03-05
Completion
2027-07-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116189 on ClinicalTrials.gov