STRONG Study
Research type
Research Study
Full title
An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies
IRAS ID
224051
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-005068-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 14 days
Research summary
Researchers have found that the body’s immune system may slow down or control cancer growth in different cancers. Sometimes, this immune system response stops, and the cancer is not killed by the immune system. Research has shown that in some patients, cancer cells and immune cells start to give messages that stop the body’s immune system from killing the cancer. One way this is done is through messengers known as PD-L1 and CTLA-4.
New drugs like durvalumab and tremelimumab increase the immune response against cancer by blocking these messages and stopping them from working.
AstraZeneca AB is sponsoring this clinical study to collect information on how these drugs work in treating different types of cancer and to better understand the side effects they may cause.
This is a multicentre study across recruiting participants into different cancer modules (Bladder, Head & Neck and Lung) which will take place across Europe and North America. It is anticipated that approximately 4000 participants will be recruited worldwide, 325 of those in the UK.
For the UK it is planned that the bladder cancer module will start first with other cancer modules starting at a later date.
Study participants in the bladder cancer module will be treated with durvalumab. Recent data suggests that this drug may treat bladder cancer and that the known side effects from the drug may be well tolerated. Different tests will be conducted to help understand the possible side effects of durvalumab and to further understand the drug’s ability to treat bladder cancer. Participants will attend the study hospital to receive treatment, for blood, urine and safety tests to be done, for the cancer to be measured and to determine any side effects.
All participants in the bladder cancer module will receive the study drug at the same dose.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1018
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion