Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:July 27, 2016
End Date:December 30, 2019
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in
combination with one of three different chemotherapies will be assessed in the treatment of
locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has
not been previously treated with chemotherapy. In Part 2, the safety and efficacy of
pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of
placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic
TNBC, which has not been previously treated with chemotherapy.

The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs
Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and
in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs
Overall Survival (OS) compared to placebo and chemotherapy in all participants and in
participants with PD-L1 positive tumors.


Inclusion Criteria:

- Has locally recurrent inoperable breast cancer not previously treated with
chemotherapy and which cannot be treated with curative intent OR has metastatic breast
cancer not previously treated with chemotherapy.

- Has centrally confirmed TNBC, as defined by the most recent American Society of
Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.

- Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months
elapsed between the completion of treatment with curative intent (e.g., date of
primary breast tumor surgery or date of last adjuvant chemotherapy administration,
whichever occurred last) and first documented local or distant disease recurrence.

- Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment
in the (neo)adjuvant setting, unless anthracycline was contraindicated or not
considered the best treatment option for the participant in the opinion of the
treating physician.

- Has measurable disease based on Response Evaluation Criteria in Solid Tumors version
1.1 (RECIST 1.1) as determined by local radiology review.

- Has provided recently or newly obtained core or excisional biopsy from a locally
recurrent inoperable or metastatic tumor lesion for central determination of TNBC
status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or
participant safety concerns.

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as
assessed within 10 days prior to the start of study drug.

- Has a life expectancy ≥12 weeks from randomization.

- Demonstrates adequate organ function, within 10 days prior to the start of study drug.

- Female participants of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 120 days (or longer as
specified by local institutional guidelines) after the last dose of study drug.

- Male participants of childbearing potential must agree to use an adequate method of
contraception starting with the first dose of study drug through 120 days (or longer
as specified by local institutional guidelines) after the last dose of study drug.

Exclusion Criteria:

- Is currently participating in a clinical study and receiving an investigational agent
and/or using an investigational device, or has participated in a clinical study and
received an investigational agent and/or used an investigational device within 4 weeks
prior to randomization.

- Has not recovered (e.g., to ≤ Grade 1 or to baseline) from AEs due to a previously
administered therapy.

- Has neuropathy ≥ Grade 2.

- Has an active autoimmune disease that has required systemic treatment in the past 2
years (e.g., with use of disease modifying agents, corticosteroids, or
immunosuppressive drugs).

- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to randomization.

- 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, and in situ
cervical cancer.

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may participate
provided they have stable brain metastases and did not receive chemotherapy for
metastatic breast cancer.

- Has history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.

- Has active, or a history of, interstitial lung disease.

- Has a known history of active tuberculosis (TB).

- Has an active infection requiring systemic therapy.

- Has a history of Class II-IV congestive heart failure or myocardial infarction within
6 months of randomization.

- Has a known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
(or longer as specified by local institutional guidelines) after the last dose of
study drug.

- Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1),
anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T
cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40,
CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical
studies.

- Has a known history of human immunodeficiency virus (HIV).

- Has known active hepatitis B or hepatitis C.

- Has received a live vaccine within 30 days prior to randomization.

- Has a known history of hypersensitivity or allergy to pembrolizumab and any of its
components and/or to any of the study chemotherapies (e.g., nab-paclitaxel,
paclitaxel, gemcitabine, or carboplatin) and any of their components.

- Is receiving any medication prohibited in combination with study chemotherapies as
described in the respective product labels, unless medication was stopped within 7
days prior to randomization.
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