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Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)

NCT02622074 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-10

Study results available
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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).

Conditions

  • Triple Negative Breast Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

200 mg administered Q3W as an IV infusion.

DRUG

Nab-paclitaxel

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

DRUG

Anthracycline (doxorubicin)

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

DRUG

Cyclophosphamide

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

DRUG

Carboplatin

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

DRUG

Paclitaxel

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2018-05-31
Completion
2019-11-18
FDA Drug
Yes

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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 NCT02622074 on ClinicalTrials.gov