Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Metastatic Triple Negative Breast Cancer

Treatments: Drug: eribulin; Drug: vinorelbine; Drug: capecitabine; Biological: pembrolizumab; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02555657

2015-001020-27 (EudraCT Number)

KEYNOTE-119 (Other Identifier)

MK-3475-119 (Other Identifier)

3475-119

153082 (Registry Identifier)

Details and patient eligibility

About

In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.

Enrollment: 622 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Centrally confirmed Stage IV/M1 mTNBC
• Newly obtained tumor biopsy from metastatic site
• Central determination of programmed cell death ligand 1 (PD-L1) tumor status
• Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
• Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
• Adequate organ function

Exclusion criteria

• Participation in another clinical trial within 4 weeks
• Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
• Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks
• Active autoimmune disease that required systemic treatment in the past 2 years
• Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days
• Known additional malignancy that required treatment or progressed in last 5 years
• Known active brain metastases and/or carcinomatous meningitis
• Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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622 participants in 2 patient groups

Pembrolizumab

Experimental group

Description:

Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Qualified participants who receive first course of pembrolizumab but continue to experience disease progression may, at investigator's discretion, initiate a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).

Treatment:

Biological: pembrolizumab

Chemotherapy

Active Comparator group

Description:

Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.

Treatment:

Drug: gemcitabine

Drug: capecitabine

Drug: vinorelbine

Drug: eribulin