Malignant MelanomaPhase 1/2NCT01138410
Study of a DNA Immunotherapy to Treat Melanoma
A Phase 1/2 study testing SCIB1 in people with Malignant Melanoma, run by Scancell Ltd at 5 sites in United Kingdom.
Trial summary
The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- SCIB1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- May 2010to 7 Jul 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Part One and Part Two (8.0 mg dose):
- Histologically confirmed Stage IV or Stage III malignant melanoma, as defined by the American Joint Committee on Cancer (AJCC).
- Must have measurable disease (RECIST 1.0)
- Part Two (4.0 mg dose) only:
- Histologically confirmed, resected Stage III or resected Stage IV malignant melanoma, as defined by the AJCC, within 12 months of resection and with no tumour detectable at the time of screening.
- Part One and Part Two:
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- HLA-A2 positive.
- Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.
- Lymphocyte count ≥ 5 x 10e9 cells/mL.
- Serum lactate dehydrogenase (LDH) ≤ upper limit of normal.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Willing and able to give written, informed consent.
- If male or female of childbearing potential, must be willing to use an effective contraceptive during the course of the study and for three months afterwards.
Who cannot join
- Known brain metastases at screening.
- Life expectancy of less than three months.
- Patients with TNM classification M1c at screening.
- Prior systemic anti-cancer treatment within four weeks of screening.
- Prior treatment with systemic corticosteroids or other immunosuppressants within four weeks of screening.
- Previous (within five years) or current malignancy at other sites with the exception of curatively treated local tumours such as carcinoma-in-situ of the cervix, basal or squamous cell carcinoma of the skin.
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- Pregnant or lactating women.
- Presence of any uncontrolled and significant medical or psychiatric condition which would interfere with trial safety assessments. Caution should be used for patients with suspected or diagnosed epilepsy.
- Any electronic stimulation device such as cardiac demand pacemaker, automatic implantable cardiac defibrillator, nerve stimulators or deep brain stimulators.
- Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid or quadriceps muscles with intact lymph drainage) exceeds 40 mm.
- Individuals with a heart rate of ≤ 50 beats per minute, history of significant cardiac abnormality and/or significant abnormal baseline electrocardiogram (ECG) readout.
- Treatment with any investigational product within the four weeks preceding screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Department of Medical Oncology, The Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
St James' Institute of Oncology
Leeds, LS9 7TF
Christie Hospital
Manchester, M20 4BX
Department of Clinical Oncology, City Hospital
Nottingham, NG5 1PB
Department of Medical Oncology, Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma
The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.
- Conditions
- Malignant Melanoma
- Being tested
- SCIB1
- Keywords
- Immunotherapy, Melanoma, Gene therapy, DNA plasmid, Cancer vaccine, Electroporation, CTL response
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIB1Biological
Aqueous solution of plasmid DNA administered by intramuscular injection using the TDS-IM electroporation device (Ichor Medical Systems, Inc.) at week 0, 3, 6, 12 and 24. Part 1 of the study will escalate through 0.4, 2.0, 4.0 and 8.0 mg dose level cohorts, each of three patients. In Part 2 of the study the 4.0 and 8.0 mg doses will be administered in the same regimen. At the discretion of the investigator, patients in both parts of the study may continue to receive SCIB1 at 3-6 month intervals for 5 years.
| Study group | Role | What they receive |
|---|---|---|
| SCIB1 | Experimental | Not described Receives: Biological: SCIB1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability
Recording and assessment of adverse events to establish safety and tolerability of an investigational immunotherapy, SCIB1, in patients with melanoma whose cancer has spread from the initial tumour (i.e., stage III or stage IV melanoma).
Measured: Duration of treatment phase: up to 5.5 years
Secondary outcomes (1)
Safety, tolerability, biological and clinical effects
(i) Recording and assessment of adverse events and patient recorded experience to establish safety and tolerability of SCIB1 administered intramuscularly to melanoma patients using the TDS IM device.
(ii) Cellular immune response by ex vivo assay induced by SCIB1 administered intramuscularly to melanoma patients using the TDS-IM device.
(iii) Tumour response by CT scan in patients treated with SCIB1 (Part One only).
Measured: Duration of treatment phase: up to 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startMay 2010
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Why it stopped: Product availability
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scancell Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Poulam M Patel, MD, Study director, Department of Clinical Oncology, City Hospital, Nottingham, UKPaul Lorigan, MD, Principal investigator, Department of Medical Oncology, Christie Hospital, Manchester, UKMaria Marples, MD, Principal investigator, St James' Institute of Oncology, Leeds, UKChristian Ottensmeier, MD, Principal investigator, Department of Medical Oncology, Southampton General Hospital, UKHardev Pandha, MD, Principal investigator, Department of Medical Oncology, Royal Surrey County Hospital, Guildford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138410
- Sponsor's protocol ID
- SCIB1-001
- Status last verified
- Aug 2017
- First submitted
- 24 May 2010
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma
- ClinicalTrials.gov ID
- NCT01138410
- Acronym / sponsor ID
- SCIB1-001
- Conditions
- Malignant Melanoma
- Keywords
- Immunotherapy, Melanoma, Gene therapy, DNA plasmid, Cancer vaccine, Electroporation, CTL response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product availability
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Scancell LtdIndustry (pharma, biotech, devices)
- Study start
- May 2010 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 7 Jun 2010 (estimated)
- 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 study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCIB1 | Experimental | Biological: SCIB1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed Stage IV or Stage III malignant melanoma, as defined by the American Joint Committee on Cancer (AJCC).
- Must have measurable disease (RECIST 1.0)
- Histologically confirmed, resected Stage III or resected Stage IV malignant melanoma, as defined by the AJCC, within 12 months of resection and with no tumour detectable at the time of screening.
- HLA-A2 positive.
- Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.
Key exclusion criteria (12 listed)
- Known brain metastases at screening.
- Life expectancy of less than three months.
- Patients with TNM classification M1c at screening.
- Prior systemic anti-cancer treatment within four weeks of screening.
- Prior treatment with systemic corticosteroids or other immunosuppressants within four weeks of screening.
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 |
|---|---|---|
| SCIB1Aqueous solution of plasmid DNA administered by intramuscular injection using the TDS-IM electroporation device (Ichor Medical Systems, Inc.) at week 0, 3, 6, 12 and 24. Part 1 of the study will escalate through 0.4, 2.0, 4.0 and 8.0 mg dose level cohorts, each of three patients. In Part 2 of the study the 4.0 and 8.0 mg doses will be administered in the same regimen. At the discretion of the investigator, patients in both parts of the study may continue to receive SCIB1 at 3-6 month intervals for 5 years. | Biological | SCIB1 |
Primary outcome
Safety & Tolerability
Time frame: Duration of treatment phase: up to 5.5 years
Recording and assessment of adverse events to establish safety and tolerability of an investigational immunotherapy, SCIB1, in patients with melanoma whose cancer has spread from the initial tumour (i.e., stage III or stage IV melanoma).
1 secondary outcome
Safety, tolerability, biological and clinical effects
Time frame: Duration of treatment phase: up to 5.5 years
Results and safety
The study was stopped early (reason given: Product availability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
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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 M Patel, MD study director
Department of Clinical Oncology, City Hospital, Nottingham, UK
Paul Lorigan, MD principal investigator
Department of Medical Oncology, Christie Hospital, Manchester, UK
Maria Marples, MD principal investigator
St James' Institute of Oncology, Leeds, UK
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCIB1 in people with Malignant Melanoma, run by Scancell Ltd at 5 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 13 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Product availability). Results are not available in the source record.
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 & Tolerability (time frame: Duration of treatment phase: up to 5.5 years). 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 21 Aug 2017.