CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 254 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/NCT02447003
NCT02447003Phase 2Completed
CompareCT.gov

A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086)

Merck Sharp & Dohme LLC·interventional·Posted May 18, 2015·Updated Dec 16, 2020

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Breast Cancer. Completed, enrolled 254 participants.

Detailed Summary

This is a two-part study of pembrolizumab monotherapy in participants with metastatic triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and safety of pembrolizumab monotherapy as first line or above treatment in participants who have received either no prior systemic treatment or at least one prior systemic treatment for metastatic breast cancer. Part 2 of the study, if done, will expand the investigation of pembrolizumab treatment in a subgroup of participants from Part 1 and will only start after enrollment in Part 1 has been completed. There will be no hypothesis testing in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 18, 2015
Enrollment StartJun 11, 2015
Primary CompletionFeb 18, 2019
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.1 years ago

Interventions

Pembrolizumabbiological

IV infusion of 200 mg.