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

NCT04079166 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SCIB1-002
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 15

Brief 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

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability assessed by the evaluation of adverse events (AEs) (Run-In Sub-Cohorts)

  National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events; CTCAE v5.0.

  Up to 30 days after the final dose of study drug

• Safety and tolerability assessed by the evaluation of vital signs, physical examination, 12-lead ECG, laboratory assessments, performance status, injection site reaction and the use of concomitant medications (Run-In Sub-Cohorts)

  Up to 30 days after the final dose of study drug

• Objective response rate (ORR) (Main Study)

  ORR assessed by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria.

  Up to 2 years (Week 97) from the first dose of study drug

Secondary Outcomes (6)

• Duration of response (Main Study)

  Up to 2 years (Week 97) from the first dose of study drug

• ORR assessed by the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Main Study)

  Up to 2 years (Week 97) from the first dose of study drug

• Progression Free Survival (PFS) rate

  Up to 2 years (Week 97) from the first dose of study drug

• Overall survival (OS) rate

  Up to 2 years (Week 97) from the first dose of study drug

• Safety and tolerability by the evaluation of AEs (Main Study)

  Up to 30 days after the final dose of study drug

Other Outcomes (2)

• Exploratory: Immune response

  Up to 30 days after the final dose of study treatment

• Exploratory: Marker expression

  Up to 30 days after the final dose of study treatment

Study Arms (1)

SCIB1 or iSCIB1+

EXPERIMENTAL

SCIB1 or iSCIB1+ administered by needle-free injection

Biological: SCIB1 or iSCIB1+ DNA vaccine

Interventions

SCIB1 or iSCIB1+ DNA vaccine BIOLOGICAL

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.

SCIB1 or iSCIB1+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of unresectable Stage III or Stage IV melanoma.
• Not received prior systemic treatment for advanced disease. Prior neoadjuvant or adjuvant treatment, defined as treatment prior to or following resection of all detectable disease, is permitted; last dose must be at least 24 weeks before the first dose of SCIB1 or iSCIB1+.
• Checkpoint inhibition with either nivolumab with ipilimumab or pembrolizumab will be an appropriate treatment for their advanced disease.
• BRAF status must be known; patients with BRAF mutation positive disease may be enrolled without BRAF inhibitor treatment at the discretion of the Investigator, provided that they have no evidence of rapidly progressing disease.
• At least one measurable lesion per RECIST 1.1 criteria by CT scan or MRI.
• Human leukocyte antigen (HLA)-A2 positive (applicable for cohort 1, 2 and 3).
• Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6 (applicable for cohort 1, 2 and 3).
• Patients for whom nivolumab with ipilimumab is determined to be an appropriate treatment will be treated in cohort 4 with iSCIB1+ if:
• the target HLA haplotype does not match as stated in criteria number 6 and 7, or
• they are unable to wait for HLA screening results prior to enrolment or starting treatment, or
• cohort 1 and cohort 3 have completed or closed to recruitment.
• At least 18 years of age.
• A life expectancy of more than 3 months.
• ECOG performance status of 0 or 1.
• Adequate organ function as determined by protocol laboratory values.

You may not qualify if:

• A diagnosis of mucosal, acral or ocular melanoma.
• Has central nervous system metastases or carcinomatous meningitis.
• Has previously received a treatment to block cytotoxic T lymphocyte associated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1), PD-L1, or programmed death-ligand 2 (PD-L2) with the following exception: patients who have received neoadjuvant or adjuvant treatment with these treatments are eligible, provided that the last dose was administered at least 24 weeks before the first dose of SCIB1 or iSCIB1+.
• Patients with lactate dehydrogenase (LDH) \> 2 x ULN.
• Expected to require any other form of systemic or localized anticancer therapy while receiving study treatment.
• Taking any systemic steroid therapy within 1 week of the first dose of study drug or is receiving any other form of immune suppressant medication. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, as well as topical and inhaled steroids, such as those for the management of asthma, are permitted.
• Receiving treatment with any investigational product within 28 days (or 5 half-lives of the treatment concerned) prior to the first dose of study treatment.
• Has a previous (within 5 years) or current malignancy with the exception of melanoma, and curatively treated local tumours.
• Has a concurrent illness which would preclude study conduct and assessment.
• Has New York Heart Association class III or IV heart disease, myocardial infarction within previous 6 months, a heart rate of ≤ 50 beats per minute, a history of significant cardiac abnormality and/or clinically significant abnormal baseline ECG reading, active ischemia, or any other uncontrolled cardiac condition.
• Has a history of severe hypersensitivity reaction to treatment with a monoclonal antibody.
• Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents (patients with vitiligo or resolved childhood asthma/atopy are an exception and are not excluded for these conditions). The following patients are not excluded from the study: patients who require intermittent use of bronchodilators or local steroid injections, patients with hypothyroidism stable on hormone replacement, and patients who receive physiological doses of steroids as replacement therapy, such as those for the management of adrenal insufficiency. In such cases the recruiting investigator should discuss the patients' eligibility with the study Medical Monitor prior to enrolment.
• Received a live vaccine within the 28 days prior to first dose of study treatment, or patient has received a non-live vaccine, including COVID-19 vaccines, within 14 days prior to first dose of study treatment.
• A known history of human immunodeficiency virus (HIV) or has any positive test for hepatitis B virus or hepatitis C virus indicating active acute or chronic infection.
• A known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.

Sponsors & Collaborators

• Scancell Ltd: lead

Study Sites (15)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Velindre University NHS Trust

Cardiff, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

East and North Hertfordshire NHS Trust

Northwood, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Oxford University Hospital NHS Foundation Trust

Oxford, United Kingdom

Location

University Hospital Plymouth NHS Trust

Plymouth, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Location

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

Somerset NHS Foundation Trust

Taunton, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Poulam Patel

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, uncontrolled study.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: September 6, 2019
• Study Start: August 19, 2019
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (15)