MK3475 vs. Standard of Care in metastatic urothelial cancer
Research type
Research Study
Full title
A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer
IRAS ID
160721
Contact name
Rob Jones
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2014-002009-40
Clinicaltrials.gov Identifier
122753, IND
Duration of Study in the UK
2 years, 0 months, 10 days
Research summary
Urothelial cancer is a term that describes tumours arising from the layer of tissue that lines the bladder, renal pelvis, ureter and urethra called the urothelial endothelium. Bladder cancer is the seventh most common cancer worldwide of which urothelial cancer accounts for approximately 90 percent of these cases.
Patients with metastatic urothelial cancer (cancer which has spread to other parts of the body) which has returned or progressed after chemotherapy generally have a poor prognosis. Most patients have an average life span of 7 to 9 months with limited treatment options. Therefore new treatment options are crucial.
Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer, but when they encounter cancer cells PD1 becomes activated by programmed cell death ligand 1 (PDL1) and PDL2 which are proteins on the surface of cancer cells. Resulting in the immune cells dying or becoming exhausted thus stopping them from attacking the cancer. Blocking PD1 activity increases the immune attack on cancers. Promising preliminary anti-cancer activity has been seen in patients with advanced urothelial cancer who express PD1. Pembrolizumab (MK-3475) inhibits the activity between PD1 and PDL1/PDL2 promoting immune cells to attack the cancer.
This study aims to evaluate the overall survival and progression free survival in patients with metastatic or advanced cancer which has returned or progressed following treatment with chemotherapy, when given Pembrolizumab (MK-3475) compared to current therapies Paclitaxel and Vinflunine.
Patients will receive either Pembrolizumab (MK-3475) or the investigators' choice of either Paclitaxel, Docetaxel or Vinflunine every 3 weeks, and be monitored regularly for safety and clinical and/or radiographic evidence of disease progression via CT or MRI scans. Bone scans will also be utilised to assess osseous metases.
About 470 patients will take part in the study which will last approximately 27 months.
The study is funded by Merck Sharp & Dohme Limited.
REC name
West of Scotland REC 1
REC reference
15/WS/0002
Date of REC Opinion
26 Jan 2015
REC opinion
Further Information Favourable Opinion