Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02555657
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
• Scientific title: A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)
• Date of first enrolment: October 13, 2015
• Target sample size: 622
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555657
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Colombia, France, Germany, Guatemala, Hong Kong, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Centrally confirmed Stage IV/M1 mTNBC

- Newly obtained tumor biopsy from metastatic site

- Central determination of programmed cell death ligand 1 (PD-L1) tumor status

- Received either one or two prior systemic treatments for metastatic breast cancer and
have documented disease progression on or after the most recent therapy

- Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or
metastatic setting

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days
prior to study start

- Adequate organ function

Exclusion Criteria:

- Participation in another clinical trial within 4 weeks

- Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks

- Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2
weeks

- Active autoimmune disease that required systemic treatment in the past 2 years

- Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form
of immunosuppressive therapy within 7 days

- Known additional malignancy that required treatment or progressed in last 5 years

- Known active brain metastases and/or carcinomatous meningitis

- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-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 previously participated in any pembrolizumab (MK-3475) clinical studies



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Triple Negative Breast Cancer

Intervention(s)

Drug: eribulin

Drug: capecitabine

Biological: pembrolizumab

Drug: vinorelbine

Drug: gemcitabine

Primary Outcome(s)

Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) =10 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Overall Survival in All Participants [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Overall Survival in Participants With PD-L1 CPS =1 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Secondary Outcome(s)

Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS =1 Who Had a Confirmed Response [Time Frame: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)]

Duration of Response Per RESIST 1.1 in All Participants Who Had a Confirmed Response [Time Frame: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)]

Number of Participants Who Discontinued Study Due to an Adverse Event [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS =1 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS =1 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS =10 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS =1 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS =10 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Number of Participants Who Experienced One or More Adverse Events [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Progression-Free Survival Per RECIST 1.1 in All Participants [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Disease Control Rate Per RECIST 1.1 in All Participants [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS =10 Who Had a Confirmed Response [Time Frame: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)]

Overall Response Rate Per RECIST 1.1 in All Participants [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS =10 [Time Frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)]

Secondary ID(s)

2015-001020-27

KEYNOTE-119

153082

3475-119

MK-3475-119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02555657