ECHO 208
Research type
Research Study
Full title
A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
IRAS ID
238522
Contact name
Martin Forster
Contact email
Sponsor organisation
Incyte Biosciences UK Ltd
Eudract number
2017-001743-12
Duration of Study in the UK
2 years, 4 months, 29 days
Research summary
In certain tumours, there are proteins (enzymes) in the body that play a role in blocking the immune system from recognising and attaching to the cancer, therefore promotes tumour growth. Targeting the immune system as an anticancer strategy is a proven and effective approach for the treatment of many times of cancer and immunotherapy is now an accepted standard of care in several tumour types.
A novel chemical drug, Epacadostat, is an immunotherapy that stops a protein called ‘IDO1’ in the immune system, responsible for the induction and maintenance of tumour immune intolerance. In addition to this chemical drug, nivolumab, ipilimumab, and lirilumab are known as ‘Checkpoint Inhibitors’ which target the immune system by blocking proteins in the body to allow an immune response. These agents have demonstrated antitumor activity as monotherapy and combined.
The trial will study for the first time the safety and efficacy of epacadostat in new combination with nivolumab and ipilimumab and with nivolumab and lirilumab.
There are two phases to the study. The main purpose of phase 1 is to choose a dose of epacadostat that is safe and tolerable in combination with: nivolumab and ipilimumab and nivolumab and lirilumab for participants with advanced or metastatic solid tumours.
The main purpose of phase 2 is to find out the efficacy of epacadostat in combination with nivolumab and ipilimumab, for participants with advanced or metastatic non-small cell lung cancer and with unrespectable or metastatic melanoma, and in combination with nivolumab and lirilumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck.
Approximately 141 patients will be enrolled: 36 participants in phase 1 and 105 patients in phase 2.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0553
Date of REC Opinion
4 Jul 2018
REC opinion
Further Information Favourable Opinion