The SCOPE Study
Research type
Research Study
Full title
A Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients with Advanced Unresectable Melanoma Receiving Either Nivolumab with Ipilimumab or SCIB1 with Pembrolizumab (The SCOPE Study)
IRAS ID
254079
Contact name
Poulam Patel
Contact email
Sponsor organisation
Scancell Ltd
Eudract number
2018-002844-10
Clinicaltrials.gov Identifier
18331, IND
Duration of Study in the UK
4 years, 2 months, 13 days
Research summary
The purpose of this study is to find out if a new treatment called SCIB1 can be used safely when added to pembrolizumab (Keytruda), a standard treatment already approved in the UK for the treatment of advanced melanoma (skin cancer). Pembrolizumab is an antibody treatment for cancer.
The study will also look to see if SCIB1 can increase the likelihood that melanoma patients will respond to pembrolizumab, and also if SCIB1 can help to make those responses last longer. Pembrolizumab is considered a standard treatment for patients with advanced melanoma. SCIB1 is considered experimental. SCIB1 has been given to melanoma patients in an earlier study. It was generally well tolerated, and researchers saw some signs that it may help to stimulate the immune system, which is a way in which the body can fight the cancer.
This study is expected to enrol approximately 25 melanoma patients from up to 8 sites in the US and UK.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0364
Date of REC Opinion
24 Jan 2019
REC opinion
Further Information Favourable Opinion