Adjuvant Cemiplimab in Cutaneous Squamous Cell Carcinoma
Research type
Research Study
Full title
A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ADJUVANT CEMIPLIMAB VERSUS PLACEBO AFTER SURGERY AND RADIATION THERAPY IN PATIENTS WITH HIGH RISK CUTANEOUS SQUAMOUS CELL CARCINOMA
IRAS ID
266879
Contact name
Sree Amarnath Challapalli
Contact email
Eudract number
2019-000566-38
Duration of Study in the UK
6 years, 2 months, 1 days
Research summary
Regeneron Pharmaceuticals, Inc. are conducting a clinical study to evaluate the safety and efficacy of an investigational drug called cemiplimab in the treatment of high risk cutaneous squamous cell cancer after surgery and radiation.
Cemiplimab is a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved in your cancer.
Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.
Approximately 412 patients will be divided into 2 treatment groups (approximately 206 patients per treatment group) at an estimated 100 sites in the North America, Europe, and Asia-Pacific regions. One group will receive cemiplimab and the other group will receive a placebo.
The study consists of 2 parts:
Part 1 (blinded): The first part of study Part 1 will last up to 48 weeks. Part 2 (unblinded): Optional cemiplimab treatment for patients on the placebo arm who experience disease recurrence and optional subsequent treatment with cemiplimab for patients on the cemiplimab arm who experience disease recurrence ≥3 months after completing 48 weeks of planned cemiplimab treatment. Patients may be treated for up to 96 weeks.
Patients will be followed-up after treatment until disease recurrence or end of study.
Because the current standard of care after radiation therapy is surveillance, placebo is the appropriate control arm to compare against cemiplimab to allow assessment of efficacy of cemiplimab as adjuvant treatment after surgery and radiation therapy.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1367
Date of REC Opinion
4 Oct 2019
REC opinion
Further Information Favourable Opinion