CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Pembrolizumab +5 morebiological
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/NCT02622074
NCT02622074Phase 1Completed
CompareCT.gov

A Phase 1b Study to Evaluate Safety and Clinical Activity of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Triple Negative Breast Cancer (TNBC) - (KEYNOTE 173)

Merck Sharp & Dohme LLC·interventional·Posted Dec 4, 2015·Updated Sep 10, 2020

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab, Nab-paclitaxel, and 4 other interventions for Triple Negative Breast Neoplasms. Completed, enrolled 60 participants.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and clinical activity of pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant treatment for participants with triple negative breast cancer (TNBC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Neoplasms
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 4, 2015
Enrollment StartJan 27, 2016
Primary CompletionMay 31, 2018
Study CompletionNov 18, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.6 years ago

Interventions

Pembrolizumabbiological

200 mg administered Q3W as an IV infusion.

Nab-paclitaxeldrug

125 mg/m\^2 or 100 mg/m\^2 administered weekly as an IV infusion, according to allocation.

Anthracycline (doxorubicin)drug

60 mg/m\^2 administered Q3W as an IV injection.

Cyclophosphamidedrug

600 mg/m\^2 administered Q3W as an IV infusion.

Carboplatindrug

AUC 6 or AUC5 administered Q3W as an IV infusion, or AUC2 administered weekly as an IV infusion, according to allocation.

Paclitaxeldrug

80 mg/m\^2 or 70 mg/m\^2 administered weekly as an IV infusion, according to allocation.