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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02447003




Registration number
NCT02447003
Ethics application status
Date submitted
14/05/2015
Date registered
18/05/2015
Date last updated
19/12/2018

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)
Scientific title
A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086)
Secondary ID [1] 0 0
2015-000294-13
Secondary ID [2] 0 0
3475-086
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pembrolizumab

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


Other interventions: Pembrolizumab
IV infusion

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Number of Participants Experiencing at Least One Adverse Event (AE)
Timepoint [2] 0 0
Up to 27 Months
Primary outcome [3] 0 0
Number of Participants Discontinuing Study Drug Due to AEs
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Merck Sharp & Dohme - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Haar
Country [19] 0 0
Italy
State/province [19] 0 0
Rome
Country [20] 0 0
New Zealand
State/province [20] 0 0
Wellington
Country [21] 0 0
Puerto Rico
State/province [21] 0 0
San Juan
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Hoddesdon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02447003
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications