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

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ClinicalTrials.gov Identifier: NCT04079166
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Scancell Ltd

Brief 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.


Condition or disease Intervention/treatment Phase
Malignant Melanoma Melanoma (Skin) Melanoma Stage III Melanoma Stage IV Biological: SCIB1 DNA vaccine Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, uncontrolled study.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: SCIB1
SCIB1 administered by intramuscular needle-free injection
Biological: SCIB1 DNA vaccine

The plan for this research study is for SCIB1 to be given for up to 85 weeks, in combination with either nivolumab with ipilimumab or pembrolizumab according to the current label.

After receiving the first dose of SCIB1, the patient will receive SCIB1 at 4, 7, 13 and 25 weeks, then every 12 weeks up to Week 85. Nivolumab with ipilimumab or pembrolizumab treatment will be started 1 week after the first dose of SCIB1 and given as per standard treatment.





Primary Outcome Measures :
  1. Safety and tolerability of SCIB1 in participants receiving either nivolumab with ipilimumab or pembrolizumab assessed by the evaluation of adverse events (AEs) and the use of concomitant medications (Run-In Sub-Cohorts) [ Time Frame: From enrolment through last recorded assessment of safety, 2 years (Week 97) from the first dose of study drug ]
    National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0.

  2. Safety and tolerability of SCIB1 in participants receiving either nivolumab with ipilimumab or pembrolizumab assessed by the evaluation of vital signs, physical examination, 12-lead ECG, laboratory assessments and performance status (Run-In Sub-Cohorts) [ Time Frame: From enrolment through end of treatment (28 days after the final dose of study treatment) ]
    Safety will be summarised for vital signs [temperature (°C).; pulse (beats per minute); respiratory rate (breaths per minute); systolic and diastolic blood pressure (mm Hg)]; physical examination of the participant (binary classification: normal or abnormal); 12-lead ECG (ECG abnormalities will be reported as an AE); laboratory assessments and grading of performance status as defined by the European Cooperative Group (ECOG) Performance Status score on a 6-point scale.

  3. Safety and tolerability of SCIB1 in participants receiving either nivolumab with ipilimumab or pembrolizumab assessed by the injection site reaction (Run-In Sub-Cohorts) [ Time Frame: From the first dose of study drug to last post-study drug assessment (3 weeks after the last dose of study drug ]
    Clinician assessment of the injection site reaction using a 3-point scale where 1 = 'mild' and 3 = 'severe'.

  4. Objective response rate (ORR) of SCIB1 in patients receiving either nivolumab with ipilimumab or pembrolizumab relative to historical data for the nivolumab with ipilimumab combination or pembrolizumab alone in this patient population (Main Study) [ Time Frame: From enrolment through last recorded assessment of response, 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.


Secondary Outcome Measures :
  1. Duration of response of SCIB1 in patients receiving either nivolumab with ipilimumab or pembrolizumab relative to historical data for the nivolumab with ipilimumab combination or pembrolizumab alone in this patient population (Main Study) [ Time Frame: From enrolment through last recorded assessment of response, up to 2 years (Week 97) from the first dose of study drug ]
    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.

  2. ORR assessed by the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Main Study) [ Time Frame: From enrollment through last recorded assessment of response, up to 2 years (Week 97) from the first dose of study drug ]
    ORR assessed by iRECIST criteria.

  3. Progression Free Survival (PFS) rate. [ Time Frame: At 1 year (Week 49) and 2 years (Week 97) from the first dose of study drug ]
    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.

  4. Overall survival (OS) rate. [ Time Frame: At 1 year (Week 49) and 2 years (Week 97) from the first dose of study drug ]
    OS rate is defined as the proportion of participants who remain alive.

  5. Safety and tolerability of SCIB1 in participants receiving either nivolumab with ipilimumab or pembrolizumab assessed by the evaluation of AEs and the use of concomitant medications (Main Study) [ Time Frame: From enrolment through last recorded assessment of safety, 2 years (Week 97) from the first dose of study drug ]
    [NCI] CTCAE v5.0.

  6. Safety and tolerability of SCIB1 in participants receiving either nivolumab with ipilimumab or pembrolizumab assessed by the evaluation of vital signs, physical examination, 12-lead ECG, laboratory assessments and performance status (Main Study) [ Time Frame: From enrolment through end of treatment (28 days after the final dose of study treatment) ]
    Safety will be summarised for vital signs [temperature (°C); pulse (beats per minute); respiratory rate (breaths per minute); systolic and diastolic blood pressure (mm Hg)]; physical examination of the participant (binary classification: normal or abnormal); 12-lead ECG (ECG abnormalities will be reported as an AE); laboratory assessments and grading of performance status as defined by the European Cooperative Group (ECOG) Performance Status score on a 6-point scale.

  7. Safety and tolerability of SCIB1 in participants receiving either nivolumab with ipilimumab or pembrolizumab assessed by the injection site reaction (Main Study) [ Time Frame: From the first dose of study drug to last post-study drug assessment (3 weeks after the last dose of study drug) ]
    Clinician assessment of the injection site reaction using a 3-point scale where 1 = 'mild' and 3 = 'severe'.


Other Outcome Measures:
  1. Exploratory: Immune response. [ Time Frame: From enrolment through end of treatment (28 days after the final dose of study treatment) ]
    Immune response to TRP-2 and gp100 peptides as measured using ELISpot and other assays on peripheral blood samples from patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of unresectable Stage III or Stage IV melanoma.
  • Not received prior systemic treatment for advanced disease. Prior adjuvant treatment, defined as treatment following resection of all detectable disease, is permitted; last dose must be at least 4 weeks before the first dose of SCIB1.
  • 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.
  • Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.
  • At least 18 years of age.
  • A life expectancy of more than 3 months.
  • An 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 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 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.

Exclusion Criteria:

  • A diagnosis of mucosal or ocular melanoma.
  • Has active central nervous system metastases or carcinomatous meningitis (patients with a response to previous treatment for brain metastases are eligible provided that they are stable without MRI evidence of progression for at least 4 weeks prior to the first dose of study treatment, and systemic steroids have been withdrawn for at least 2 weeks).
  • 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 adjuvant treatment with these treatments are eligible.
  • 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 vaccine within the 28 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079166


Contacts
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Contact: Robert Miller +44 (0)1865 582 690 info@scancell.co.uk

Locations
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United Kingdom
Velindre University NHS Trust Recruiting
Cardiff, United Kingdom
Contact: Satish Kumar, MD         
Principal Investigator: Satish Kumar, MD         
Guy's & St Thomas' NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Amanda Fitzpatrick, MD         
Principal Investigator: Amanda Fitzpatrick, MD         
Royal Free London NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Amna Sheri, MD         
Principal Investigator: Amna Sheri, MD         
East and North Hertfordshire NHS Trust Recruiting
Northwood, United Kingdom
Contact: Heather Shaw, MD         
Principal Investigator: Heather Shaw, MD         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Poulam M Patel, MD         
Principal Investigator: Poulam M Patel, MD         
Oxford University Hospital NHS Foundation Trust Recruiting
Oxford, United Kingdom
Contact: Miranda Payne, MD         
Principal Investigator: Miranda Payne, MD         
University Hospital Plymouth NHS Trust Recruiting
Plymouth, United Kingdom
Contact: Martin Highley, MD         
Principal Investigator: Martin Highley, MD         
Lancashire Teaching Hospitals NHS Foundation Trust Recruiting
Preston, United Kingdom
Contact: Kellati Prasad, MD         
Principal Investigator: Kellati Prasad, MD         
Sheffield Teaching Hospital NHS Foundation Trust Recruiting
Sheffield, United Kingdom
Contact: Sarah Danson, MD         
Principal Investigator: Sarah Danson, MD         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom
Contact: Ioannis Karydis, MD         
Principal Investigator: Ioannis Karydis, MD         
Somerset NHS Foundation Trust Recruiting
Taunton, United Kingdom
Contact: Gihan Ratnayake, MD         
Principal Investigator: Gihan Ratnayake, MD         
Sponsors and Collaborators
Scancell Ltd
Investigators
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Principal Investigator: Poulam Patel University of Nottingham
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Responsible Party: Scancell Ltd
ClinicalTrials.gov Identifier: NCT04079166    
Other Study ID Numbers: SCIB1-002
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
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