A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) – (KEYNOTE-086) - A Phase II Study of Pembrolizumab in Subjects with Triple-Negative Breast Cancer

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites254 target enrollmentJune 18, 2015

ConditionsTriple-Negative Breast Cancer Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Triple-Negative Breast Cancer
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 254
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 18, 2015

End Date

January 31, 2020

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•For Cohorts A and C (2L\+ monotherapy), potential subjects must:
•1\. Have received at least one systemic treatment for metastatic breast cancer and have documented disease progression on the most recent therapy. Subjects must have been previously treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting.
•Note for Cohort A: In the event that the interim analysis shows that pembrolizumab monotherapy is futile in subjects with PD\-L1 (\-) mTNBC, subsequent enrollment to Cohort A may be limited to subjects with PD\-L1 (\+) tumors. If this is the case, sites will be notified via a Protocol Clarification Letter.
•For Cohort B (1L monotherapy), potential subjects must:
•2\. Have not received prior systemic anti\-cancer therapy for mTNBC, and
•3\. Have PD\-L1 (\+) mTNBC.
•For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.
•For Cohort C (2L\+ monotherapy), potential subjects must:
•4\. Have PD\-L1 strong (\+) mTNBC, i.e. subject’s tumor must meet or exceed the PD\-L1 cut point for high positivity.
•For all cohorts, potential subjects must:

Exclusion Criteria

•1\. Is 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 of the first dose of treatment.
•Note: Subjects who have entered the follow\-up phase of an investigational study may participate as long as it has been 4 weeks since the last dose of the previous investigational agent or device.
•2\. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•3\. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•4\. Has had a prior anti\-cancer monoclonal antibody (mAb) for direct anti\-neoplastic treatment within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•5\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
•Note: Subjects with \= Grade 2 neuropathy or alopecia of any grade are an exception to this criterion and may qualify for the study.
•Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•6\. Has a 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.
•7\. Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system (CNS) metastases and/or carcinomatous meningitis. Brain imaging at screening is required.