Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SCIB1 in Melanoma Patients Receiving Pembrolizumab SCIB1-002

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079166
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Scancell Ltd

Brief Summary:

The purpose of this study is to find out if a new treatment called SCIB1 can be used safely when added to pembrolizumab (Keytruda), a standard therapy approved for the treatment of advanced melanoma (skin cancer). Pembrolizumab is an antibody treatment for cancer.

The study will also look to see if SCIB1 can increase the likelihood that melanoma patients will respond to pembrolizumab, and also if SCIB1 can help to make those responses last longer. Pembrolizumab is considered a standard treatment for patients with advanced melanoma. 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.

This study is expected to enrol approximately 25 melanoma patients worldwide.


Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: SCIB1 administered with a small, hand-held electroporation device (TDS-IM v2.0). Device: Electroporation device (TDS-IM v 2.0). Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 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, Multicenter, Open-Label Study of SCIB1 in Patients With Advanced Unresectable Melanoma Receiving Pembrolizumab
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: SCIB1
SCIB1 administered using the TDS-IM v2.0 device
Biological: SCIB1 administered with a small, hand-held electroporation device (TDS-IM v2.0).

SCIB1 to be given for up to 2 years, The plan for this research study is for SCIB1 to be given for up to 2 years, in combination with pembrolizumab according to the current label.

After the initial dose of SCIB1, the patient will then receive SCIB1 3 times, 3 weeks apart, then once 6 weeks later, and after that once every 12 weeks until the treatment is stopped.

Pembrolizumab will be given by an infusion into the patient's vein once every 3 weeks. This normally takes about 30 minutes to complete.

Every time the patient has a SCIB1 infusion, they will also receive pembrolizumab. Additionally, there will also be some days when the patient will receive pembrolizumab alone.

On each occasion, SCIB1 will be given by two injections into a muscle in a different limb, e.g. one into the upper arm and the other into the thigh. Instead of a normal needle and syringe, a small, hand-held electroporation device (TDS-IM v2.0) will be used to inject SCIB1 into the muscles.


Device: Electroporation device (TDS-IM v 2.0).
The small, hand-held electroporation device (TDS-IM v2.0) will be used to administer SCIB1 for up to 2 years.




Primary Outcome Measures :
  1. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of adverse events (AEs) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks ]
    National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0.

  2. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (temperature) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Temperature (°C).

  3. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (pulse) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Pulse (beats per minute).

  4. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (respiratory rate) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Respiratory rate (breaths per minute).

  5. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (blood pressure) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Systolic and diastolic blood pressure (mm Hg).

  6. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by a physical examination of the participant (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Physical examination of eyes, neurological and cardiovascular systems, lungs, abdomen, head, neck, ears, nose, mouth, throat, thyroid, lymph nodes, extremities, and other areas with signs and symptoms of disease (binary classification: normal or clinically significant).

  7. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (creatinine, bilirubin, uric acid) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Creatinine, bilirubin - total, bilirubin - direct (if clinically indicated), uric acid (μmol/L).

  8. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (including blood urea nitrogen) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Blood urea nitrogen, bicarbonate (or carbon dioxide), calcium, chloride, potassium, sodium, non-fasting glucose, phosphorus, uric acid (mmol/L).

  9. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (including alanine aminotransferase) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase (international units/L).

  10. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Albumin) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Albumin, total protein (g/L).

  11. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Thyroid-stimulating hormone) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Thyroid-stimulating hormone (mIU/L).

  12. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Free thyroxine, triiodothyronine) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Free thyroxine, triiodothyronine (pmol/L).

  13. Safety and tolerability of SCIB1 in participants as assessed by hematology (red blood cell count) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Red blood cell count (10⌃12/L).

  14. Safety and tolerability of SCIB1 in participants as assessed by hematology (including hematocrit) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Hematocrit, neutrophils to leukocyte ratio, lymphocytes to leukocyte ratio, monocytes to leukocyte ratio, eosinophils to leukocyte ratio, basophils to leukocyte ratio (%).

  15. Safety and tolerability of SCIB1 in participants as assessed by hematology (including leukocytes) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Leukocytes, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, platelets (10⌃9/L).

  16. Safety and tolerability of SCIB1 in participants as assessed by hematology (corpuscular volume) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Mean corpuscular volume (fL).

  17. Safety and tolerability of SCIB1 in participants as assessed by hematology (corpuscular hemoglobin) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Mean corpuscular hemoglobin (pg).

  18. Safety and tolerability of SCIB1 in participants as assessed by hematology (hemoglobin, corpuscular hemoglobin) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Hemoglobin, mean corpuscular hemoglobin concentration (g/L).

  19. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (protein, glucose) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Protein, glucose (negative/trace/1+/2+/3+/4+).

  20. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (ketones, hemoglobin) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Ketones, hemoglobin (negative/trace/1+/2+/3+).

  21. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (pH) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    pH (pH units).

  22. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (specific gravity) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Specific gravity.

  23. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (white blood cells, red blood cells) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    If clinically indicated: white blood cells and red blood cells (cells per high power field).

  24. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (bacteria, casts and crystals) (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    If clinically indicated: microscopic examination for bacteria, casts and crystals (binary classification: positive or negative).

  25. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by 12-lead electrocardiogram (Run-In Cohort: first 6 participants enrolled) [ Time Frame: At 6 weeks after the first dose of SCIB1 or pembrolizumab, and at end of treatment (28 days after the final dose of study drug). ]
    Evaluation of standard components of the 12-lead ECG. Information regarding standard components of the ECG will not be collected systematically; however, in cases where an ECG abnormality is identified, the abnormality will be reported as an AE, and all details of the identified abnormality will be provided.

  26. Safety and tolerability of SCIB1 in participants as assessed by performance status (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Grading of performance status as defined by the European Cooperative Group (ECOG) Performance Status score on a 6-point scale, where 0 = 'fully active, able to carry on all pre-disease performance without restriction' and 5 = 'dead'.

  27. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the injection site reaction (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Clinician assessment of the injection site reaction using a 3-point scale where 1 = 'mild' and 3 = 'severe'.

  28. Tolerability of SCIB1 in participants as assessed by a tolerability questionnaire (Run-In Cohort: first 6 participants enrolled) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Patient assessment of the tolerability of the injection using a 5-point scale where 1 = 'no sensation' and 5 = 'extreme pain'.

  29. Objective response rate (ORR) of SCIB1 in patients receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Objective response as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.


Secondary Outcome Measures :
  1. Effect on duration of response of SCIB1 in patients receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    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 of SCIB1 in participants receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population, based on the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Main Study) [ Time Frame: At 1 year from the first dose of SCIB1 for the last patient enrolled, and at 1 year after the last dose of SCIB1 or pembrolizumab (whichever occurs last) for each participant. ]
    ORR as determined by iRECIST criteria.

  3. Progression Free Survival (PFS) rate for all participants at 1 year and 2 years (96 weeks) following initiation of treatment [ Time Frame: At 1 year and 2 years (96 weeks) from the first dose of SCIB1 or pembrolizumab. ]
    PFS rate at 1 year and 2 years, defined as the proportion of participants who have not progressed (per RECIST 1.1), or started new anticancer therapy, or died at time points of 1 year and 2 years (96 weeks) from the first dose of SCIB1 or pembrolizumab

  4. Overall survival (OS) rate at 1 and 2 years (96 weeks) following initiation of treatment [ Time Frame: At 1 year and 2 years (96 weeks) from the first dose of SCIB1 or pembrolizumab. ]
    OS rate at 1 year, defined as the proportion of participants who remain alive 1 year after the first dose of SCIB 1 or pembrolizumab. The same assessment will be made at 2 years (96 weeks) from the first dose of study drug.

  5. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of adverse events (AEs) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks ]
    National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0.

  6. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (temperature) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Temperature (°C).

  7. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (pulse) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Pulse (beats per minute).

  8. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (respiratory rate) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Respiratory rate (breaths per minute).

  9. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (blood pressure) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Systolic and diastolic blood pressure (mm Hg).

  10. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by a physical examination of the participant (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Physical examination of eyes, neurological and cardiovascular systems, lungs, abdomen, head, neck, ears, nose, mouth, throat, thyroid, lymph nodes, extremities, and other areas with signs and symptoms of disease (binary classification: normal or clinically significant).

  11. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (creatinine, bilirubin, uric acid) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Creatinine, bilirubin - total, bilirubin - direct (if clinically indicated), uric acid (μmol/L).

  12. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (including blood urea nitrogen) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Blood urea nitrogen, bicarbonate (or carbon dioxide), calcium, chloride, potassium, sodium, non-fasting glucose, phosphorus, uric acid (mmol/L).

  13. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (including Alanine aminotransferase) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase (international units/L).

  14. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Albumin) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Albumin, total protein (g/L).

  15. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Thyroid-stimulating hormone) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Thyroid-stimulating hormone (mIU/L).

  16. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Free thyroxine, triiodothyronine) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Free thyroxine, triiodothyronine (pmol/L). Free thyroxine, triiodothyronine (pmol/L).

  17. Safety and tolerability of SCIB1 in participants as assessed by hematology (red blood cell count) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Red blood cell count (10⌃12/L).

  18. Safety and tolerability of SCIB1 in participants as assessed by hematology (including hematocrit) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Hematocrit, neutrophils to leukocyte ratio, lymphocytes to leukocyte ratio, monocytes to leukocyte ratio, eosinophils to leukocyte ratio, basophils to leukocyte ratio (%).

  19. Safety and tolerability of SCIB1 in participants as assessed by hematology (including leukocytes) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Leukocytes, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, platelets (10⌃9/L).

  20. Safety and tolerability of SCIB1 in participants as assessed by hematology (corpuscular volume) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Mean corpuscular volume (fL).

  21. Safety and tolerability of SCIB1 in participants as assessed by hematology (corpuscular hemoglobin) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Mean corpuscular hemoglobin (pg).

  22. Safety and tolerability of SCIB1 in participants as assessed by hematology (haemoglobin, corpuscular hemoglobin) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Hemoglobin, mean corpuscular hemoglobin concentration (g/L).

  23. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (protein, glucose) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Protein, glucose (negative/trace/1+/2+/3+/4+).

  24. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (ketones, hemoglobin) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Ketones, hemoglobin (negative/trace/1+/2+/3+).

  25. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (pH) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    pH (pH units).

  26. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (specific gravity) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Specific gravity.

  27. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (white blood cells, red blood cells) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    If clinically indicated: white blood cells and red blood cells (cells per high power field).

  28. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (bacteria, casts and crystals) (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    If clinically indicated: microscopic examination for bacteria, casts and crystals (binary classification: positive or negative).

  29. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by 12-lead electrocardiogram (Main Study) [ Time Frame: At 6 weeks after the first dose of SCIB1 or pembrolizumab, and at end of treatment (28 days after the final dose of study drug). ]
    Evaluation of standard components of the 12-lead ECG. Information regarding standard components of the ECG will not be collected systematically; however, in cases where an ECG abnormality is identified, the abnormality will be reported as an AE, and all details of the identified abnormality will be provided.

  30. Safety and tolerability of SCIB1 in participants as assessed by performance status (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Grading of performance status as defined by the European Cooperative Group (ECOG) Performance Status score on a 6-point scale, where 0 = 'fully active, able to carry on all pre-disease performance without restriction' and 5 = 'dead'.

  31. Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the injection site reaction (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Clinician assessment of the injection site reaction using a 3-point scale where 1 = 'mild' and 3 = 'severe'.

  32. Tolerability of SCIB1 in participants as assessed by a tolerability questionnaire (Main Study) [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Patient assessment of the tolerability of the injection using a 5-point scale where 1 = 'no sensation' and 5 = 'extreme pain'.


Other Outcome Measures:
  1. Exploratory: Immune response. [ Time Frame: From enrollment through end of treatment; up to 96 weeks. ]
    Immune response to TRP-2 and gp100 peptides as measured using an interferon gamma (IFNγ) enzyme-linked immunospot [ELISpot] assay on peripheral blood samples from patients at a limited number of sites (IFN spot number per 5 x 10⌃4 cells).



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.


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

Inclusion Criteria:

  • Patient has histologically confirmed, unresectable Stage III or Stage IV melanoma as defined by the American Joint Committee on Cancer (AJCC) (Gershenwald et al 2017).
  • Patient has 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.
  • Patient has been clinically evaluated and pembrolizumab has been determined to be an appropriate treatment for their advanced disease.
  • Patient's 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 progressive disease (PD) (lactate dehydrogenase [LDH] above normal range, clinically significant tumor-related symptoms).
  • Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI). Cutaneous and other superficial lesions are non-target lesions and are not considered measurable for the purposes of this protocol.
  • Patient has an archival or fresh biopsy sample of tumor available for analysis of immunological markers including expression of programmed death-ligand 1 (PD-L1).
  • Patient is HLA-A2 positive.[*]
  • Patient is positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.[*]
  • Patient is at least 18 years of age.
  • Patient has a life expectancy of more than 3 months.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient has adequate organ function as determined by protocol laboratory values.

[*] HLA testing will be conducted at accredited laboratories by molecular (DNA) typing.

  • Patient must be able and willing to provide written IRB/REC-approved informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new IRB/REC-approved ICF must be signed.)
  • Women of child-bearing potential (including women ≤ 12 months from last menstrual period) must have a negative serum pregnancy test during Screening (within the 72 hours before planned administration of the first dose of study drug on Day 1) and be neither breastfeeding nor intending to become pregnant during study participation, and shall be warned of potential fetal harm from pembrolizumab. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of SCIB1 or pembrolizumab, whichever occurs last.
  • Men who are potentially fertile with partners of childbearing potential must agree to use highly effective contraceptive methods for the duration of study participation and for 120 days after discontinuation of study treatment.
  • Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  • Patient has a diagnosis of uveal or ocular melanoma.
  • Patient 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).
  • Patient has previously received a treatment to block cytotoxic T lymphocyte (CTL)-associated protein 4 (CTLA-4), 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.
  • Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
  • Patient is taking any systemic steroid therapy within one week of the first dose of study drug or is receiving any other form of immune suppressant medication. Topical and inhaled steroids, such as those for the management of asthma, are permitted.
  • Patient is receiving treatment with any investigational product within 28 days (or 5 half-lives of the treatment concerned if longer than 28 days) prior to the first dose of study treatment.
  • Patient has a previous (within 5 years) or current malignancy with the exception of melanoma, and curatively treated local tumors such as carcinoma-in-situ of the breast, cervix, basal or squamous cell carcinoma of the skin, prostate cancer with Gleason grade < 6 and prostate specific antigen within normal range.
  • Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, or uncontrolled diabetes mellitus, or pulmonary disease (including obstructive pulmonary disease, pulmonary fibrosis, and history of symptomatic bronchospasm), or alcoholic liver disease, or primary biliary cirrhosis. Caution should be used for patients with suspected or diagnosed epilepsy.
  • Patient has any electronic stimulation device such as cardiac demand pacemaker, automatic implantable cardiac defibrillator, nerve stimulator or deep brain stimulator.
  • Patient has a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid or quadriceps muscles with intact lymph drainage) that is > 50 mm.
  • Patient has New York Heart Association (NYHA) 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 such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, uncontrolled hypertension (> 140/90 mm Hg), significant cerebrovascular disease, or congestive heart failure.
  • Patient has a history of severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb).
  • Patient 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). Patients that require intermittent use of bronchodilators or local steroid injections, and patients with hypothyroidism stable on hormone replacement, are not excluded from the study.
  • Patient has received a vaccine within the 28 days prior to first dose of study treatment.
  • Patient has a known history of human immunodeficiency virus (HIV) or has any positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating active acute or chronic infection.
  • Patient has 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
Layout table for location contacts
Contact: Sally Adams +44 (0)1865 582 690 info@scancell.co.uk

Locations
Layout table for location information
United Kingdom
Velindre University NHS Trust Not yet recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Satish Kumar, MD         
Principal Investigator: Satish Kumar, MD         
East and North Hertfordshire NHS Trust Not yet recruiting
Northwood, United Kingdom, HA6 2RN
Contact: Heather Shaw, MD         
Principal Investigator: Heather Shaw, MD         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Poulam M Patel, MD    +44 115 8231850    poulam.patel@nottingham.ac.uk   
Principal Investigator: Poulam M Patel, MD         
Oxford University Hospital NHS Foundation Trust Not yet recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Miranda Payne, MD         
Principal Investigator: Miranda Payne, MD         
Sponsors and Collaborators
Scancell Ltd
Investigators
Layout table for investigator information
Principal Investigator: Poulam Patel University of Nottingham
Layout table for additonal information
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: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas