SCIB1 in Melanoma Patients Receiving Either Nivolumab With Ipilimumab or Pembrolizumab (The SCOPE Study)

Melanoma (Skin) Clinical Trial

Official title: A Phase 2, Multicentre, Open-Label Study of SCIB1 in Patients With Advanced Unresectable Melanoma Receiving Either Nivolumab With Ipilimumab or Pembrolizumab (The SCOPE Study)

Status Recruiting

Clinical Trial Summary

The purpose of this study is to find out if a new treatment cancer vaccine called SCIB1 can be used safely when added to either nivolumab (Opdivo) with ipilimumab (Yervoy) or pembrolizumab (Keytruda), standard treatments approved for patients with advanced melanoma (skin cancer).

The study will also look to see if SCIB1 can increase the likelihood that melanoma patients will respond to either nivolumab with ipilimumab or pembrolizumab, and also if SCIB1 can help to make those responses last longer. 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.

Clinical Trial Description

This is an open label, single arm Phase 2 study to determine the safety and tolerability of intramuscular SCIB1 when added to either nivolumab (Opdivo) with ipilimumab (Yervoy) or pembrolizumab (Keytruda), standard treatments already approved for the treatment of advanced melanoma.

The plan for this study is for SCIB1 to be given up to 10 times for 85 weeks, in combination with either nivolumab with ipilimumab or pembrolizumab according to the current label. The SCIB1 injection will be given using PharmaJet Stratis® needle-free injection device system in the upper arm or upper leg.

Before treatment starts and after consent has been given, all patients will undergo screening tests (to be completed within 28 days of treatment initiation) to ensure the patient is eligible to take part. Over the 85-week treatment period, the patient will visit the hospital multiple times and have some telephone/video calls. The evaluations and procedures that will be carried out at each visit are all detailed in the study information sheets given to the patient before consent is taken.

In response to the COVID-19 pandemic, the treatment burden for patients has also been reduced where possible by conducting remote assessments via telephone or video conference. ;

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Melanoma (Skin)
• Melanoma Stage III
• Melanoma Stage IV

• NCT number: NCT04079166
• Study type: Interventional
• Source: Scancell Ltd
• Contact: Robert Miller
• Phone: +44 (0)1865 582 690
• Email: info@scancell.co.uk
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2019
• Completion date: January 31, 2026