DURANCE
Research type
Research Study
Full title
A phase Ib/II study to assess the safety and activity of DURvalumab (MEDI4736) in combination with S-488210/S-488211 vAccine in Non-muscle invasive bladder CancEr
IRAS ID
263559
Contact name
Rubina Begum
Contact email
Sponsor organisation
University College London
Eudract number
2019-002312-50
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 2 months, 31 days
Research summary
Bladder cancer is the 9th most common cancer in the world. In about 70% of patients the disease only involves the cells that line the inner layer of the bladder (i.e. the cancer has not invaded the muscular wall of the bladder) and is known as Non-Muscle Invasive Bladder Cancer (NMIBC).
Patients with NMIBC that are at risk of the cancer invading the muscular wall usually have surgery to remove as much of their cancer, followed by BCG vaccine administered into the cells lining the bladder. However, in around 40% of patients the cancer returns and they require radical cystectomy (to remove the bladder) which carries significant risk of health issues or death.
Immunotherapy has been used to treat bladder cancer for over 40 years and the addition of vaccine to immunotherapy is hoped to improve the way immunotherapy treatment works.
Durvalumab is an immunotherapy treatment that works by stimulating the immune system to block cancer growth or other activities needed for cancer growth. S-488210/S-488211 are 2 vaccines that can potentially increase the number of different types of immune cells the immune system needs to stop cancer growth.
DURANCE is a trial looking at the safety and activity of combining durvalumab with S-488210/S-488211 in patients with NMIBC whose cancer has returned.
The study will be conducted in two parts. Phase Ib will recruit 14 patients to assess if it is safe to combine durvalumab and S-488210/S-488211. If considered safe, will recruit 50 more patients in phase II. Data collected from all 64 patients will be used to look at how the combined treatment works by measuring their disease at 1 year after starting treatment.
Patients will receive up to 24 weeks of trial treatment provided the treatment appears to be working and then followed up for 5 years from the start of treatment.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0016
Date of REC Opinion
16 Mar 2020
REC opinion
Further Information Favourable Opinion