Epacadostat and nivolumab in Selected Advanced Cancers
Research type
Research Study
Full title
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers
IRAS ID
213155
Contact name
Michael Dudley
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2016-002423-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 28 days
Research summary
Cancer is a disease where cells within the body divide abnormally causing growths called tumours. There are over 100 different types of cancers and ones which commonly affect people in the UK are cancers of the lungs, skin (known as melanoma), and lymph nodes (glands within the body – known as lymphoma). Cancers are quite common diseases and around 350 000 people in the UK were diagnosed with cancer in 2015.
Cancers can be caused by many different things and often it is impossible to know what causes the disease in an individual. This clinical trial is investigating the use of a new drug called epacadostat or INCB024360 when given in combination with another cancer treatment called nivolumab for the treatment of several different types of cancer.
The developers of the drug want to see how well the drug works, what effects it has on the cancer and what side effects are seen. With this study, patients with advanced cancers (this means the cancer has spread from where it initially was in the body) will be given epacadostat to take orally whilst also being given intravenous infusions of another drug called nivolumab. Epacadostat and nivolumab should help the body fight the cancer by boosting the immune system. The immune system is the part of the body that fights diseases. The hope is that by using these drugs together the tumours will shrink and that this will be beneficial to patients.
This clinical trial is being run in a number of centres in the USA as well as in the UK. The Sponsor of the study is Incyte Corporation. In total around 300 patients are expected to be involved in the trial.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0158
Date of REC Opinion
13 Jul 2017
REC opinion
Further Information Favourable Opinion