Malignant MelanomaPhase 2NCT04079166
SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)
A Phase 2 study testing SCIB1 or iSCIB1+ DNA vaccine in people with Malignant Melanoma and Melanoma (Skin), run by Scancell Ltd at 15 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Melanoma (Skin), Melanoma Stage III
- What is being tested?
- SCIB1 or iSCIB1+ DNA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 19 Aug 2019to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- Able and willing to provide written informed consent prior to any study related procedure.
- 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.
- 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.
- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Velindre University NHS Trust
Cardiff
The Leeds Teaching Hospitals NHS Trust
Leeds
Guy's & St Thomas' NHS Foundation Trust
London
Royal Free London NHS Foundation Trust
London
The Royal Marsden NHS Foundation Trust
London
The Christie NHS Foundation Trust
Manchester
East and North Hertfordshire NHS Trust
Northwood
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospital NHS Foundation Trust
Oxford
University Hospital Plymouth NHS Trust
Plymouth
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield
University Hospital Southampton NHS Foundation Trust
Southampton
Somerset NHS Foundation Trust
Taunton
About this study
Official title: A Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)
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.
Read the detailed description
This is an open label, single arm Phase 2 study to determine the response rate and safety and tolerability of SCIB1 or iSCIB1+ when added to nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab (Keytruda). Pembrolizumab or nivolumab with ipilimumab are standard treatments already approved for the treatment of advanced melanoma.
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.
- Being tested
- SCIB1 or iSCIB1+ DNA vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIB1 or iSCIB1+ DNA vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| SCIB1 or iSCIB1+ | Experimental | SCIB1 or iSCIB1+ administered by needle-free injection Receives: Biological: SCIB1 or iSCIB1+ DNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: Up to 2 years (Week 97) from the first dose of study drug
Secondary outcomes (6)
Duration of response (Main Study)
Duration of response, measured from the point of first response (complete response or partial response) to the date of disease progression (per RECIST 1.1) or death due to any cause.
Measured: 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)
ORR assessed by iRECIST criteria.
Measured: Up to 2 years (Week 97) from the first dose of study drug
Progression Free Survival (PFS) rate
PFS rate is defined as the proportion of participants who have not progressed (per RECIST 1.1 and iRECIST), or started new anticancer therapy, or died.
Measured: Up to 2 years (Week 97) from the first dose of study drug
Overall survival (OS) rate
OS rate is defined as the proportion of participants who remain alive.
Measured: Up to 2 years (Week 97) from the first dose of study drug
Safety and tolerability by the evaluation of AEs (Main Study)
NCI CTCAE v5.0.
Measured: Up to 30 days after the final dose of study drug
Safety and tolerability by the evaluation of vital signs, physical examination, 12-lead ECG, laboratory assessments, performance status, injection site reaction and the use of concomitant medications (Main Study)
Measured: Up to 30 days after the final dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start19 Aug 2019
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, uncontrolled study.
- Masking
- None (open label)
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scancell Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Poulam Patel, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079166
- Sponsor's protocol ID
- SCIB1-002
- Status last verified
- Dec 2025
- First submitted
- 16 Aug 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)
- ClinicalTrials.gov ID
- NCT04079166
- Acronym / sponsor ID
- SCIB1-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Scancell LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open label, single arm Phase 2 study to determine the response rate and safety and tolerability of SCIB1 or iSCIB1+ when added to nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab (Keytruda). Pembrolizumab or nivolumab with ipilimumab are standard treatments already approved for the treatment of advanced melanoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, uncontrolled study.
| Arm | Type | Receives |
|---|---|---|
| SCIB1 or iSCIB1+ | Experimental | Biological: SCIB1 or iSCIB1+ DNA vaccineSCIB1 or iSCIB1+ administered by needle-free injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCIB1 or iSCIB1+ DNA vaccineParticipants 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. | Biological | SCIB1 or iSCIB1+ |
Primary outcome
Safety and tolerability assessed by the evaluation of adverse events (AEs) (Run-In Sub-Cohorts)
Time frame: Up to 30 days after the final dose of study drug
National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0.
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)
Time frame: Up to 30 days after the final dose of study drug
Objective response rate (ORR) (Main Study)
Time frame: Up to 2 years (Week 97) from the first dose of study drug
ORR assessed by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria.
6 secondary outcomes
Duration of response (Main Study)
Time frame: 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)
Time frame: Up to 2 years (Week 97) from the first dose of study drug
Progression Free Survival (PFS) rate
Time frame: Up to 2 years (Week 97) from the first dose of study drug
Overall survival (OS) rate
Time frame: Up to 2 years (Week 97) from the first dose of study drug
Safety and tolerability by the evaluation of AEs (Main Study)
Time frame: Up to 30 days after the final dose of study drug
Safety and tolerability by the evaluation of vital signs, physical examination, 12-lead ECG, laboratory assessments, performance status, injection site reaction and the use of concomitant medications (Main Study)
Time frame: Up to 30 days after the final dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poulam Patel principal investigator
University of Nottingham
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCIB1 or iSCIB1+ DNA vaccine in people with Malignant Melanoma and Melanoma (Skin), run by Scancell Ltd at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability assessed by the evaluation of adverse events (AEs) (Run-In Sub-Cohorts) (time frame: Up to 30 days after the final dose of study drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.