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 in participants who have
received either no prior systemic treatment or at least one prior systemic treatment for
metastatic breast cancer. 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. There will be no hypothesis testing in this study.
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
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | MK-3475 | Pembrolizumab |
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
Name | Type | Description | Interventions |
---|
Pembrolizumab | Experimental | Participants 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
Last Updated
November 23, 2017