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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 14, 2015
Last updated: March 15, 2017
Last verified: March 2017
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 Intervention Phase
Breast Cancer
Biological: Pembrolizumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Estimated Enrollment: 245
Study Start Date: June 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: MK-3475


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
  • 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 metastatic tumor lesion not previously irradiated
  • 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 medication
  • Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
  • Adequate organ function

Exclusion Criteria:

  • Currently participating and receiving study therapy, 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 medication
  • 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 pneumonitis requiring treatment with steroids
  • 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 trial
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial medication
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) or has participated in Merck MK-3475 trials
  • 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 medication
  Contacts and Locations
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Please refer to this study by its identifier: NCT02447003

  Show 27 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02447003     History of Changes
Other Study ID Numbers: 3475-086
2015-000294-13 ( EudraCT Number )
152987 ( Registry Identifier: JAPIC )
Study First Received: May 14, 2015
Last Updated: March 15, 2017

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on April 26, 2017