Phase I of Pembrolizumab (MK-3475) in Pts with non small cell lung cancer
Research type
Research Study
Full title
Phase I study of a single agent Pembrolizumab (MK-3475) in patients with progressive locally advanced or metastatic carcinoma, melanoma and non-small cell lung cancer (KEYNOTE 001)
IRAS ID
130084
Contact name
Gary Middleton
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)
Eudract number
2011-002371-42
Clinicaltrials.gov Identifier
11,080, US IND Number
Duration of Study in the UK
4 years, 5 months, 25 days
Research summary
The drug being tested in this study is a PD1 inhibitor called MK3475. PD1 is present on the surface of cells of the immune system which fight cancer but when they encounter cancer cells PD1 becomes activated by PDL1 on the surface of the cancer cells. This has the effect of making the immune cells die or become exhausted thus stopping them from attacking the cancer. Blocking PD1 activity increases the immune attack on cancers. PD1 inhibitors have already achieved impressive results in lung cancer and this study will look at how active MK3475 is in lung cancer.
The purpose of this study is to see how safe and well tolerated MK3475 is when given to non-smallcell lung cancer (NSCLC) patients and to obtain early insights into the activity of MK3475 in treating tumours.
Lung cancer remains a huge problem in the UK and a massive area of unmet therapeutic need. It is the second most common cancer with 41,428 new cases in 2009 but is the most common cause of cancer death. In 2010, there were 34,859 deaths from lung cancer in the UK. Thus, the search for new treatments is crucial and arming the immune system is one intriguing new approach.Patients with NSCLC which express PDL1 on the surface of the cancer cells will be eligible.
Patients in Part F1 will not have received previous treatment for their cancer. They will receive MK3475at 10 mg/kg with a dosing interval of every 2 weeks (Q2W) or every 3 weeks(Q3W). 88 patients will be recruited
Patients in Part F2 who have received previous lung cancer treatment will also receive 10 mg/kg MK3475at dosing intervals of either Q2W or Q3W. 150 patients will receive 10 mg/kg Q3W and 100 patients will receive 10 mg/kg Q2W.Patients will be monitored regularly for safety and clinical and/orradiographic evidence of disease progressionaccording to usual standardspractice.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0273
Date of REC Opinion
27 Jun 2013
REC opinion
Further Information Favourable Opinion