MK-3475 + Chemotherapy as Neoadjuvant and Adjuvant therapy for TNBC
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
IRAS ID
221524
Contact name
Peter Schmid
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2016-004740-11
Duration of Study in the UK
7 years, 10 months, 28 days
Research summary
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer death in women. Breast cancer that tests negative for oestrogen receptors, progesterone receptors and human epidermal growth factor receptor-2 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.
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. Interaction between these ligands and the receptors present on the immune cells prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This Phase III study will last approximately 8 years and will recruit 855 adult men/women over the age of 18. Each participant will take part in the trial for approximately 67 weeks from the time they sign the Informed Consent Form through completion of study treatment.The primary purpose of this study is to compare the rate of pathological complete response (pCR) and event-free survival in treatment with pembrolizumab plus chemotherapy versus placebo plus chemotherapy as neoadjuvant (preoperative) therapy and pembrolizumab versus placebo as adjuvant (post-surgery) therapy for TNBC. Secondary outcomes test the use of tumour PD-L1 as a biomarker (a biological parameter indicating a biological condition) for correlation to pembrolizumab response.
The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/0347
Date of REC Opinion
24 Apr 2017
REC opinion
Further Information Favourable Opinion