Clinical Trials /

Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)

NCT02447003

Description:

This is a two-part study of pembrolizumab monotherapy in participants with metastatic triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and safety of pembrolizumab monotherapy as first line or above treatment. Part 2 of the study, if done, will expand the investigation of pembrolizumab treatment in a subgroup of participants from Part 1 and will only start after enrollment in Part 1 has been completed.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)
  • Official Title: A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086)

Clinical Trial IDs

  • ORG STUDY ID: 3475-086
  • SECONDARY ID: 2015-000294-13
  • SECONDARY ID: 152987
  • NCT ID: NCT02447003

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Pembrolizumab

Purpose

This is a two-part study of pembrolizumab monotherapy in participants with metastatic triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and safety of pembrolizumab monotherapy as first line or above treatment. Part 2 of the study, if done, will expand the investigation of pembrolizumab treatment in a subgroup of participants from Part 1 and will only start after enrollment in Part 1 has been completed.

Detailed Description

      Participants who discontinue study treatment after 24 months of therapy for reasons other
      than disease progression or intolerability or who discontinue treatment after attaining a
      Complete Response (CR) may be eligible for up to one year of retreatment after they have
      experienced disease progression by tumor imaging.
    

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimentalParticipants receive pembrolizumab, 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 24 months.

    Eligibility Criteria

            Inclusion Criteria:
    
            For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not
            count as a prior line of therapy.
    
            For Cohorts A and C:
    
              -  At least one systemic treatment for metastatic breast cancer
    
              -  Documented disease progression on or after the most recent therapy
    
              -  Prior treatment must include an anthracycline and a taxane in the neoadjuvant,
                 adjuvant, or metastatic setting
    
            For Cohort B:
    
              -  No prior systemic treatment for metastatic breast cancer
    
              -  Programmed cell death-ligand 1 (PD-L1)-positive mTNBC.
    
            For Cohort C:
    
            - PD-L1 strong positive mTNBC
    
            For all cohorts:
    
              -  mTNBC confirmed by a central laboratory
    
              -  For biomarker analysis, adequate newly obtained core or excisional biopsy of a
                 not-previously-irradiated metastatic tumor lesion (mandatory)
    
              -  Measurable metastatic disease
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    
              -  Female participants of childbearing potential should be willing to use 2 methods of
                 birth control or be surgically sterile, or abstain from heterosexual activity for the
                 course of the study through 120 days after the last dose of study treatment
    
              -  Male participants should agree to use an adequate method of contraception starting
                 with the first dose of study treatment through 120 days after the last dose of study
                 treatment
    
              -  Adequate organ function
    
            Exclusion Criteria:
    
              -  Currently participating and receiving study treatment, or has participated in a study
                 of an investigational agent and received study therapy or used an investigational
                 device within 4 weeks prior to study Day 1
    
              -  Prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic
                 treatment within 4 weeks prior to study Day 1
    
              -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy within at
                 least 2 weeks prior to study Day 1
    
              -  Not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents
                 administered within at least 2 weeks prior to study Day 1
    
              -  Active autoimmune disease requiring systemic treatment in past 2 years
    
              -  Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
                 of immunosuppressive therapy within 7 days prior to the first dose of study treatment
    
              -  Known additional malignancy that progressed or required active treatment within the
                 last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell
                 carcinoma of the skin that has undergone potentially curative therapy, or in situ
                 cervical cancer
    
              -  Radiographically-detectable central nervous system (CNS) metastases and/or
                 carcinomatous meningitis
    
              -  History of (non-infectious) pneumonitis that required steroids or current pneumonitis
                 or a history of interstitial lung disease
    
              -  Active infection requiring systemic therapy
    
              -  Known psychiatric or substance abuse disorders that would interfere with cooperation
                 with the requirements of the study
    
              -  Pregnant, breastfeeding, or expecting to conceive or father children within the
                 projected duration of the study, starting with the screening visit through 120 days
                 after the last dose of study treatment
    
              -  Prior therapy with an anti-programmed cell death protein-1 (anti-PD-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 has
                 participated in Merck MK-3475 (pembrolizumab) study
    
              -  Known history of human immunodeficiency virus (HIV)
    
              -  Known active Hepatitis B or C
    
              -  Received a live vaccine within 30 days of planned start of study treatment
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall Response Rate (ORR)
    Time Frame:Up to 24 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Duration of Response (DOR)
    Time Frame:Up to 24 months
    Safety Issue:
    Description:
    Measure:Disease Control Rate (DCR)
    Time Frame:Up to 24 months
    Safety Issue:
    Description:
    Measure:Progression-free Survival (PFS)
    Time Frame:Up to 24 months
    Safety Issue:
    Description:
    Measure:Overall Survival (OS)
    Time Frame:Up to 24 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Merck Sharp & Dohme Corp.

    Trial Keywords

    • PD1
    • PD-1
    • PDL1
    • PD-L1

    Last Updated

    November 23, 2017