Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
IRAS ID
258311
Contact name
Irene De Francesco
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2018-001974-76
Duration of Study in the UK
7 years, 1 months, 3 days
Research summary
Cutaneous squamous cell carcinoma is the second most common non-melanoma skin cancer. Most patients with this cancer are successfully treated with surgical treatment, however some patients are at risk for local recurrence and spreading of the cancer.
If the cancer spreads it can have a devastating impact on patients, therefore it is important to develop treatments to decrease recurrence rate without compromising the patients’ quality of life.The aim of the study is:
- To test the safety of pembrolizumab and how well your body handles pembrolizumab.
- To see if giving pembrolizumab after surgery and radiation helps patients with your type of cancer live longer.
- To see how well pembrolizumab keeps your type of cancer from coming back or spreading compared to placebo. A placebo looks like study drug but has no medicine in it.Participants will be assigned randomly in 1:1 ratio to one of the two treatment arms, treatment arm A, patients receive Pembrolizumab and in treatment arm B patients receive placebo.
The drug being tested in this study is Pembrolizumab (MK3475) also known as KEYTRUDA®. Pembrolizumab works by helping your immune system to fight your cancer. Pembrolizumab, has been approved by certain health authorities for the treatment of various cancers including melanoma, however it has not yet been approved for use in patients with locally advanced cutaneous squamous cell carcinoma.
Approximately 570 participants, aged 18 years or over, who have been diagnosed with High-risk locally advanced cutaneous squamous cell carcinoma will enter this Phase 3 study. The study will last about 8 years. This includes the time on study drug and in follow up to see if your cancer has come back or spread.
The study is funded by Merck Sharp & Dohme Limited and will take place at six study centres in the UK.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0031
Date of REC Opinion
4 Mar 2019
REC opinion
Further Information Favourable Opinion