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Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

NCT02819518 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 882

Last updated 2024-11-27

Study results available
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Summary

The study will consist of two parts.

In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy.

In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.

The primary hypotheses are that:

1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in:

* all participants,
* participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and
* participants with PD-L1 CPS ≥10 tumors, and
2. the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in:

* all participants,
* participants with PD-L1 CPS ≥1 tumors, and
* participants with PD-L1 CPS ≥10 tumors.

Conditions

  • Triple Negative Breast Cancer (TNBC)

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Normale Saline Solution

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-27
Primary Completion
2021-06-15
Completion
2023-10-30

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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 NCT02819518 on ClinicalTrials.gov