Trial Purpose

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 Tumours (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 tumours (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.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT05116189

When speaking to your doctor, please have the trial identifier number available.

About The Study

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Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.

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Dates

  • Actual study start date 13 December 2021
  • Estimated primary completion date 30 June 2025
  • Estimated study completion date 31 August 2027

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

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Conditions

Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Cancer

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Age Range

18 - No Age Maximum

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Sex

Female

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.