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SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

NCT04079166 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2025-12-19

No results posted yet for this study

Summary

The purpose of this study is to find out if two new treatment cancer vaccines called SCIB1 and iSCIB1+ can be used safely when added to nivolumab (Opdivo) with ipilimumab (Yervoy), or SCIB1 with pembrolizumab (Keytruda). Pembrolizumab or nivolumab with ipilimumab are standard treatments approved for patients with advanced melanoma (skin cancer).

The study will also look to see if SCIB1 or iSCIB1+ can increase the likelihood that melanoma patients will respond to the standard treatments, and also if SCIB1 and iSCIB1+ can help to make those responses last longer. SCIB1 and iSCIB1+ are 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. iSCIB1+ is similar to SCIB1 but might benefit more patients with melanoma.

Conditions

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

Interventions

BIOLOGICAL

SCIB1 or iSCIB1+ DNA vaccine

Participants receive up to 11 doses of either SCIB1 or iSCIB1+ up to 85 weeks, in combination with nivolumab with ipilimumab or SCIB1 with pembrolizumab. Nivolumab with ipilimumab or pembrolizumab treatment will be started 1 week after the first dose of SCIB1 or iSCIB1+ and given as per standard treatment.

Sponsors & Collaborators

  • Scancell Ltd

    lead INDUSTRY

Principal Investigators

  • Poulam Patel · University of Nottingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079166 on ClinicalTrials.gov