SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)
NCT ID: NCT04079166
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
173 participants
INTERVENTIONAL
2019-08-19
2027-01-31
Brief Summary
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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.
Detailed Description
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The plan for this study is for SCIB1 or iSCIB1+ to be given up to 11 times for 85 weeks, in combination with nivolumab with ipilimumab or SCIB1 with pembrolizumab. The standard treatments will be given according to the current label. The SCIB1 or iSCIB1+ injection will be given using PharmaJet needle-free injection device systems 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SCIB1 or iSCIB1+
SCIB1 or iSCIB1+ administered by needle-free injection
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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+.
3. Checkpoint inhibition with either nivolumab with ipilimumab or pembrolizumab will be an appropriate treatment for their advanced disease.
4. 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.
5. At least one measurable lesion per RECIST 1.1 criteria by CT scan or MRI.
6. Human leukocyte antigen (HLA)-A2 positive (applicable for cohort 1, 2 and 3).
7. Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6 (applicable for cohort 1, 2 and 3).
8. Patients for whom nivolumab with ipilimumab is determined to be an appropriate treatment will be treated in cohort 4 with iSCIB1+ if:
1. the target HLA haplotype does not match as stated in criteria number 6 and 7, or
2. they are unable to wait for HLA screening results prior to enrolment or starting treatment, or
3. cohort 1 and cohort 3 have completed or closed to recruitment.
9. At least 18 years of age.
10. A life expectancy of more than 3 months.
11. ECOG performance status of 0 or 1.
12. Adequate organ function as determined by protocol laboratory values.
13. Able and willing to provide written informed consent prior to any study related procedure.
14. Women of child-bearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation, and shall be warned of potential foetal harm from nivolumab with ipilimumab or pembrolizumab. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the whole duration of study treatment, and for 120 days after discontinuation of SCIB1 or iSCIB1+, or nivolumab with ipilimumab, or pembrolizumab, whichever is last.
15. Men who are potentially fertile with partners of childbearing potential must agree to use highly effective contraceptive methods for the whole duration of study treatment, and for 120 days after discontinuation of SCIB1 or iSCIB1+, or nivolumab with ipilimumab, or pembrolizumab, whichever is last.
16. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
2. Has central nervous system metastases or carcinomatous meningitis.
3. 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+.
4. Patients with lactate dehydrogenase (LDH) \> 2 x ULN.
5. Expected to require any other form of systemic or localized anticancer therapy while receiving study treatment.
6. 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.
7. 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.
8. Has a previous (within 5 years) or current malignancy with the exception of melanoma, and curatively treated local tumours.
9. Has a concurrent illness which would preclude study conduct and assessment.
10. 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.
11. Has a history of severe hypersensitivity reaction to treatment with a monoclonal antibody.
12. 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.
13. 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.
14. 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.
15. A known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.
18 Years
ALL
No
Sponsors
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Scancell Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Poulam Patel
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Velindre University NHS Trust
Cardiff, , United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
East and North Hertfordshire NHS Trust
Northwood, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford University Hospital NHS Foundation Trust
Oxford, , United Kingdom
University Hospital Plymouth NHS Trust
Plymouth, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Somerset NHS Foundation Trust
Taunton, , United Kingdom
Countries
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Other Identifiers
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SCIB1-002
Identifier Type: -
Identifier Source: org_study_id