A Phase 3 Study of Durvalumab in Muscle Invasive Bladder Cancer
Research type
Research Study
Full title
A Phase III, Randomized, OPen-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitibine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer (NIAGARA)
IRAS ID
252394
Contact name
Tom Powles
Contact email
Sponsor organisation
AstraZeneca UK
Eudract number
2018-001811-59
Duration of Study in the UK
6 years, 9 months, 13 days
Research summary
This study is being conducted to find out if Durvalumab combined with the standard of treatment will work and be safe for the treatment of Muscle Invasive Bladder Cancer (MIBC).
The study will be conducted at sites with expertise in the treatment of MIBC across 20 countries. In order to participate patients must be aged 18 years or above and have histologically or cytologically documented MIBC. Patients will be required to provide a MIBC tumour sample prior to study entry.
The study involves a screening period, treatment period, and a follow-up period. The screening period will last approximately 1 month, and may require a few visits to determine whether you can take part in the study. The study treatment period will occur if you meet all the criteria to take part in the study, you will be assigned randomly to one of two treatments groups which will be followed by a surgery to remove your bladder.
Lastly the follow-up period you will be asked to continue to come to the hospital so your study doctor may check your health and follow up any ongoing side effects or discomfort until they get better if you stop your treatment for any reason. The amount of time on the study will depend on your response.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1861
Date of REC Opinion
19 Nov 2018
REC opinion
Favourable Opinion