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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02447003
Ethics application status
Date submitted
14/05/2015
Date registered
18/05/2015

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
Treatment: Other - Pembrolizumab

Experimental: Cohort A: Pembrolizumab - Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants will be administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to \~ 2 years).

Experimental: Cohort B: Pembrolizumab - Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants will be administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to \~ 2 years).


Treatment: Other: Pembrolizumab
IV infusion of 200 mg.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Central Imaging Vendor (CIV) in All Cohort A Participants
Timepoint [1] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Primary outcome [2] 0 0
ORR Per RECIST 1.1 by CIV in Subgroup of Cohort A Participants With Programmed Cell Death- Ligand 1 (PD-L1) Positive Tumor Expression
Timepoint [2] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Primary outcome [3] 0 0
Number of Participants Who Experienced at Least One Adverse Event (AE)
Timepoint [3] 0 0
Up to ~31 months
Primary outcome [4] 0 0
Number of Participants Who Discontinued Study Drug Due to an AE
Timepoint [4] 0 0
Up to ~31 months
Secondary outcome [1] 0 0
ORR Per RECIST 1.1 by CIV in All Cohort B Participants
Timepoint [1] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [2] 0 0
Duration of Response (DOR) Per RECIST 1.1 by CIV in All Cohort A and Cohort B Participants
Timepoint [2] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [3] 0 0
DOR Per RECIST 1.1 by CIV in Subgroup of Cohort A Participants With PD-L1 Positive Tumor Expression
Timepoint [3] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [4] 0 0
Disease Control Rate (DCR) Per RECIST 1.1 by CIV in All Cohort A and Cohort B Participants
Timepoint [4] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [5] 0 0
DCR Per RECIST 1.1 by CIV in Subgroup of Cohort A Participants With PD-L1 Positive Tumor Expression
Timepoint [5] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [6] 0 0
Progression Free Survival (PFS) Per RECIST 1.1 by CIV in All Cohort A and Cohort B Participants
Timepoint [6] 0 0
Up to ~28 months (through pre-specified final statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [7] 0 0
PFS Per RECIST 1.1 by CIV in Subgroup of Cohort A Participants With PD-L1 Positive Tumor Expression
Timepoint [7] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [8] 0 0
Overall Survival (OS) in All Cohort A and Cohort B Participants
Timepoint [8] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [9] 0 0
OS in Subgroup of Cohort A Participants With PD-L1 Positive Tumor Expression
Timepoint [9] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)
Secondary outcome [10] 0 0
Odds Ratio of Association Between PD-L1 Tumor Expression and Objective Response (OR) Per RECIST 1.1 by CIV in Cohort A Participants
Timepoint [10] 0 0
Up to ~28 months (through pre-specified statistical analysis cut-off date of 10-Nov-2017)

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 second line plus monotherapy (Parts 1 and 2):

* Has received at least one systemic treatment for metastatic breast cancer
* Has 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 first line monotherapy (Part 1):

* Has received no prior systemic treatment for metastatic breast cancer
* Has PD-L1-positive mTNBC.

For second line plus monotherapy (Part 2):

- Has PD-L1 strong positive mTNBC

For all parts:

* Has 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)
* Has measurable metastatic disease
* Has 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
* Has adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is 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
* Has received prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic treatment within 4 weeks prior to study Day 1
* Has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1
* Has 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
* Has an active autoimmune disease requiring systemic treatment in past 2 years
* Has a 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
* Has 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
* Has radiographically-detectable central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis or a history of interstitial lung disease
* Has an active infection requiring systemic therapy
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
* Is 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
* Has received 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
* Has a known history of human immunodeficiency virus (HIV)
* Has known active Hepatitis B or C
* Has received a live vaccine within 30 days of planned start of study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2020
Sample size
Target
Accrual to date
Final
254
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02447003