Clinical Trials /

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

NCT02555657

Description:

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 (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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
  • Official Title: A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)

Clinical Trial IDs

  • ORG STUDY ID: 3475-119
  • SECONDARY ID: 2015-001020-27
  • SECONDARY ID: 153082
  • NCT ID: NCT02555657

Conditions

  • Metastatic Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
pembrolizumabMK-3475, KEYTRUDA®Pembrolizumab
capecitabineChemotherapy
eribulinChemotherapy
gemcitabineChemotherapy
vinorelbineChemotherapy

Purpose

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 (TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends progression free and/or overall survival compared to TPC

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimentalParticipants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations.
    ChemotherapyActive ComparatorParticipants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
    • capecitabine
    • eribulin
    • gemcitabine
    • vinorelbine

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall Survival (OS)
    Time Frame:Up to 37 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall Response Rate (ORR)
    Time Frame:Up to 37 months
    Safety Issue:
    Description:
    Measure:Disease Control Rate (DCR)
    Time Frame:Up to 37 months
    Safety Issue:
    Description:
    Measure:Progression Free Survival (PFS)
    Time Frame:Up to 37 Months
    Safety Issue:
    Description:
    Measure:Duration of Overall Response (DOR)
    Time Frame:Up to 37 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Merck Sharp & Dohme Corp.

    Trial Keywords

    • PD1
    • PD-1
    • PDL1
    • PD-LI

    Last Updated

    September 22, 2017