ECHO 206:epacadostat in combination with pembrolizumab and azacitadine
Research type
Research Study
Full title
A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer
IRAS ID
226184
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2016-004289-25
Duration of Study in the UK
4 years, 2 months, 1 days
Research summary
This is an open-label, multicentre Phase 1/2 study evaluating the addition of an epigenetic priming regeme to an immunotherapy doublet in participants with advanced or metastatic solid tumours. Epacadostat(INCB024360) is an investigational drug that is being studied for use in the treatment of advanced solid tumours or certain tumour types such as melanoma, non-small cell lung cancer colorectal cancer, head and neck squamous cell carcinoma, ovarian cancer, glioblastoma, and diffuse large B cell lymphoma (DLBCL).
Epacadostat is a chemical drug that stops a protein (also called an enzyme) in the body called indoleamine-2, 3-dioxygenase-1 (IDO1) from making your immune system less active.
Azacitidine is a chemical drug that cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to the body’s normal growth control mechanisms.
Blocking both IDO1 (indoleamine 2,3-dioxygenase) and PD-1 (programmed death receptor-1) may help the body’s immune system fight cancer. Pembrolizumab treatment is investigational when given in combination with epacadostat, and azacitidine for the treatment of advanced solid tumours.
This study is in two parts:The purpose of the Study in Part 1 is to assess which doses of the investigational treatment are safe and tolerable in participants who have advanced solid tumours.
Part 2 of this study will assess if the investigational treatment works in preventing disease progression in participants with Stage IIIB or IV non-small cell lung cancer or microsatellite-stable colorectal cancer.
Participants will be male or female aged 18 years or older on day of signing the consent form. Sites will be NHS hospital locations and the study is expected to last for 6 months, although study doctors may continue to follow on participants for an additional 12 months.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/1043
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion