A Phase III Study of Pembrolizumab + Chemotherapy in 1L TNBC
Research type
Research Study
Full title
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)
IRAS ID
207909
Contact name
Peter Schmid
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2016-001432-35
Duration of Study in the UK
3 years, 5 months, 0 days
Research summary
Breast cancer is the most commonly diagnosed cancer and second leading cause of cancer death in women. Breast Cancer that tests negative for estrogen receptors (ER), progesterone receptors (PGR) and human epidermal growth factor receptor2 (HER2) is known as Triple negative breast cancer (TNBC). TNBC represents 15-20% of all breast cancers.
Treatment of TNBC is challenging and represents an area of unmet medical need, as these tumours lack therapeutic targets, and become rapidly resistant to chemotherapy upon local recurrence and/or metastasis (cancer which spreads).
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing immune attack on cancers.
This Phase III study will last approximately 41 months and will be conducted in 2 parts. The purpose of this study is to investigate how effective combination of pembrolizumab and chemotherapy is in treatment of adults with locally recurrent inoperable or metastatic TNBC which has not been previously treated with chemotherapy.
Approximately 30 adult men/women will be recruited in Part 1, unblinded, partially randomized study, of which the purpose is to evaluate safety and tolerability of 3 pembrolizumab chemotherapy combinations.
Approximatelly 828 adult men/women will be recruited in Part 2, double-blind, randomised, placebo controlled study, which purpose is to compare PFS and OS in treatment with combination of pembrolizumab and chemotherapy versus placebo and chemotherapy.
The study is funded by Merck Sharp & Dohme Limited and will take place at 7 study centres in UK.REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/1106
Date of REC Opinion
18 Jul 2016
REC opinion
Favourable Opinion