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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02447003
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : February 18, 2020
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: Pembrolizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086)
Actual Study Start Date : June 11, 2015
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab, 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 24 months.
Biological: Pembrolizumab
IV infusion
Other Name: MK-3475

Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]
  2. Number of Participants Experiencing at Least One Adverse Event (AE) [ Time Frame: Up to 27 Months ]
  3. Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  2. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
  3. Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
  4. Overall Survival (OS) [ Time Frame: Up to 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02447003

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02447003    
Other Study ID Numbers: 3475-086
2015-000294-13 ( EudraCT Number )
152987 ( Registry Identifier: JAPIC )
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents