At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 376 enrolled

Drug / intervention

Pembrolizumabbiological

Likely dose

Pembrolizumab 200 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02674061

NCT02674061Phase 2Completed

Compare CT.gov

A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)

Merck Sharp & Dohme LLC·interventional·Posted Feb 4, 2016·Updated Mar 24, 2022

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Ovarian Neoplasms. Completed, enrolled 376 participants.

Detailed Summary

This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC) who have received up to 5 prior lines of treatment including platinum-based treatment for ROC (1 to 6 total prior lines counting front line therapy). Participants will be enrolled into two separate cohorts based on the number of prior lines of treatment received for ROC. There will be no hypothesis testing in this study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOvarian Neoplasms

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedFeb 2016

Enrollment StartFeb 2016

Primary CompletionSep 2019

Study CompletionMar 2021

TodayJul 2026

First PostedFeb 4, 2016

Enrollment StartFeb 25, 2016

Primary CompletionSep 18, 2019

Study CompletionMar 18, 2021

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 10.4 years ago

Interventions

Pembrolizumabbiological

Administered at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle