INCMGA00012 in Patients with Metastatic Merkel Cell Carcinoma
Research type
Research Study
Full title
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma
IRAS ID
248465
Contact name
Dr James Larkin
Contact email
Sponsor organisation
Incyte Biosciences Distribution B.V.
Eudract number
2018-001627-39
Clinicaltrials.gov Identifier
139,181, IND Number
Duration of Study in the UK
3 years, 2 months, 23 days
Research summary
This is an open-label, monotherapy (single therapy) study of INCMGA00012 in participants with metastatic Merkel Cell Carcinoma (MCC)(a rare, aggressive cancer of the skin).
INCMGA00012 is a monoclonal antibody. When the body’s immune system detects something harmful, it produces antibodies. Antibodies are proteins that fight infection. Monoclonal antibodies are a specific type of antibody made in a laboratory. They can attach to other molecules or cells in the body and affect their function.
Some cancer cells hide from the body’s immune system by taking control of what is called the PD-1 pathway, which is a pathway normal healthy cells use to tell the immune system not to attack them. INCMGA00012 is made to attach to the PD-1 protein and block this pathway, allowing the immune system to recognise and attack the cancer cells, which is an accepted way to treat many types of cancer.This study is designed to assess the clinical activity and safety of INCMGA00012.
Participants will sign an informed consent form and undergo screening procedures. If they meet the inclusion/exclusion criteria, they will be enrolled into the study and will receive the study treatment (INCMGA00012) administered at the dose of 500 mg intravenously (through a vein) once every 28 days.
Participants will undergo regular safety assessments during treatment as well as regular efficacy assessments.
They may receive treatment with this study drug for up to 2 years (unless prematurely discontinued due to disease progression or unacceptable toxicity).Their total participation in this study could last up to about 3 years.
The study will enrol approximately 90 participants in total.
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0379
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion