Study of Avelumab Plus Best Supportive Care in Urothelial Cancer
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB*(MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
IRAS ID
202257
Contact name
Thomas Powles
Contact email
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eudract number
2015-003262-86
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
126,217, United States (US) Investigational New Drug (IND) Number
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Urothelial Cancer (UC) includes tumours that began from cells lining the bladder and urinary tract. Bladder cancer alone accounts for 90% of UC, and is the ninth most common type of cancer worldwide.
The main purpose of this research study is to compare the study drug avelumab given in combination with best supportive care (BSC), with BSC alone, to see if avelumab helps increase overall survival in patients with advanced UC that cannot be removed by surgery. Participants taking part in this study is limited those whose disease did not worsen during platinum-based chemotherapy. A normal plan following this chemotherapy is to “watch and wait” for the cancer to worsen before starting another treatment. This research study begins during that usual waiting period.
Eligible participants will be assigned by chance (like flipping a coin) to receive avelumab plus BSC or BSC alone. Participants assigned to “Arm A” will receive an avelumab infusion every 2 weeks. Participants assigned to “Arm B” will receive BSC alone. BSC includes usual care, such as antibiotics, nutritional support, correction of metabolic disorders, symptom control, and pain management, but does not include treatment for the actual cancer.
This study is open-label, so participants and study doctors will know the treatment assignment.
How long a participant will be in this study will depend on how the cancer responds, side effects, and the participant's/ study doctor's decision to continue study treatment. After the treatment part of the study, there is a short-term and long-term follow-up phase.
Study procedures will include: vital signs and physical examinations; questions about daily performance and symptoms; ECG; tumour assessments; tumour biopsy; urine and blood tests.
This study is being sponsored by Pfizer. Approximately 668 participants will take part in the study, with approximately 30 participants in the UK.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0877
Date of REC Opinion
12 Jul 2016
REC opinion
Further Information Favourable Opinion