DISCUS
Research type
Research Study
Full title
A randomised phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer
IRAS ID
1003775
Contact name
Thomas Powles
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2021-001975-17
Research summary
A study to determine if 3 cycles of combination chemotherapy followed by maintenance avelumab improves quality of life for patients whilst maintaining the same level of effectiveness as the current standard of 6 cycles of combination chemotherapy followed by maintenance avelumab. Avelumab is a human monoclonal antibody indicated in the treatment of metastatic urothelial tumours. Avelumab is designed to stop a protein called PD-L1 (programmed death-ligand 1) being expressed on the cancer, allowing the immune system to recognise the tumour cells as foreign bodies and attack them. There are strict eligibility criteria for this trial. Broadly speaking, patients with histologically confirmed locally advanced or metastatic urothelial cancer are eligible. Patients must also not have received prior treatment for their cancer and surgical treatment must not be considered suitable. This study will recruit patients from hospitals in the UK and Spain. Eligible patients will be randomised to receive one of two possible treatments. Patients will receive either 3 or 6 cycles of gemcitabine plus cisplatin/carboplatin at 21-day intervals. Following completion of either 3 or 6 cycles of chemotherapy patients will then commence maintenance avelumab on a 28 day cycle, which can be given for up to two years. If a patient stops study treatment they will be followed up 12 weekly from the end of the chemotherapy for a maximum of 2 years for their disease progress/survival. Patients should complete quality of life questionnaires and attend CT scan visits at timepoints throughout the study. The study team will compare the patient’s quality of life questionnaires, scan results and side effects between the two treatment arms to determine if receiving 3 cycles of chemotherapy improves quality of life whilst maintaining the effectiveness of 6 cycles. Many of the procedures in this study are offered as standard of care and participation in this trial will not delay patients commencing treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0694
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion