Malignant MelanomaPhase 1/2NCT01559818
A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001
A Phase 1/2 study testing IMM-101 in people with Malignant Melanoma, run by Immodulon Therapeutics Ltd at 1 site in United Kingdom.
Trial summary
Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study. Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken. 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?
- IMM-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Jul 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient was previously enrolled in Study IMM-101-001
- Patient gave consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor
- Patient gave signed informed consent for participation in the study
Who cannot join
- Female patient of child-bearing potential who was not, in the opinion of the Investigator, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]).
- Those patients that utilised hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) was discontinued from being used concomitantly with the hormonal contraception.
- Patient of non-child-bearing potential were defined as having 12 month amenorrhoea or were surgically sterile.
- Female patient who was pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
- Patient was unable or unwilling to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Long Term Follow up Study for Patients With Melanoma Who Were Previously Enrolled in the Phase I Study IMM-101-001
Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study.
Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken.
The treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days.
The overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use.
Read the detailed description
This was an open-label long term follow up study. The study consisted of two phases:
- Screening and enrolment Patients, who provided informed consent participated in a screening period of up to 28 days to establish eligibility. Once eligibility was confirmed a full disease and treatment history covering the period from their completion of Study IMM-101-001 to date was taken.
- Treatment Patients could receive ongoing treatment every 4 weeks or as close to this interval as permitted due to practical or logistic considerations until death or withdrawal, unless such therapy was contraindicated, the patient did not wish to continue or the study was terminated by the Sponsor. At no point could the elapsed period between IMM-101 doses be less than 14 days.
Patients could choose to withdraw from the study at any time and for any reason. IMM-101 could be stopped or the dosing regimen reduced if felt to be necessary by the Investigator and/or patient (e.g., intolerable injection site reactions).
In the event of an injection site reaction of Grade 3 and above, and/or if significant ulceration, tenderness or lymphadenopathy was observed, at the discretion of the Investigator, patients could be administered a half dose of the study drug (i.e., a single 0.05 mL intradermal injection of IMM-101) or the timing of the injection could be delayed. If the dosing interval was increased, the patient still attended the study site for safety assessments preferably every 3 months but, if this was not possible, every 6 months at a minimum. The blood sample for exploratory analysis continued to be taken every 6 months.
Any change in the dose of study drug administered or the frequency of dose administration was recorded in the patient's case report form (CRF). In the case of withdrawal, separate consent was sought to allow the continued collection on patient status.
- Conditions
- Malignant Melanoma
- Being tested
- IMM-101
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-101Biological
Also called Heat-killed whole cell M. obuense
IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
| Study group | Role | What they receive |
|---|---|---|
| IMM-101 | Experimental | IMM-101 1.0 mg administered intradermally Receives: Biological: IMM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events With a Causal Relationship to IMM-101
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. Treatment related Adverse Events were defined as being definitely, probably or possibly related to IMM-101 or with an unknown relationship.
Measured: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities
Measured: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Treatment Emergent Serious Adverse Events
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities.
There were no IMM-101 related serious adverse events reported during the study.
Measured: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Secondary outcomes (2)
Survival
Overall survival
Measured: Overall survival was defined as the time from enrolment until date of death for up to 81 months. Patients still alive after 81 months were censored at withdrawal from the study or at last known date alive if later.
Incidence of Change in Metastatic Disease
The protocol required any change in metastatic disease to be documented where possible. However, given this was a real-life long-term follow-up study, CT or MRI scans were not mandated as part of the protocol and were only performed as clinically indicated. Very few scans were performed during the course of the study (0 to nine events per patient). Given the fact patients could receive anti-cancer therapy on study, disease status fluctuated throughout the study (better, worse, no change). This coupled with the sparsity of CT or MRI scan data collected on a per patient basis resulted in only Best Overall Response being described.
Measured: From Informed Consent to death or withdrawal (median 4.4 years, range 1.2 - 6.7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2019
- Study completionJul 2019
Why it stopped: Sponsor considered no further meaningful data was being collected, nor were likely to be collected in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immodulon Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Fusi, Dr, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559818
- Sponsor's protocol ID
- IMM-101-008
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2012
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Long Term Follow up Study for Patients With Melanoma Who Were Previously Enrolled in the Phase I Study IMM-101-001
- ClinicalTrials.gov ID
- NCT01559818
- Acronym / sponsor ID
- IMM-101-008
- Conditions
- Malignant Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor considered no further meaningful data was being collected, nor were likely to be collected in the future.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Immodulon Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study.
Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken.
The treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days.
The overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use.
Detailed description
This was an open-label long term follow up study. The study consisted of two phases:
- Screening and enrolment Patients, who provided informed consent participated in a screening period of up to 28 days to establish eligibility. Once eligibility was confirmed a full disease and treatment history covering the period from their completion of Study IMM-101-001 to date was taken.
- Treatment Patients could receive ongoing treatment every 4 weeks or as close to this interval as permitted due to practical or logistic considerations until death or withdrawal, unless such therapy was contraindicated, the patient did not wish to continue or the study was terminated by the Sponsor. At no point could the elapsed period between IMM-101 doses be less than 14 days.
Patients could choose to withdraw from the study at any time and for any reason. IMM-101 could be stopped or the dosing regimen reduced if felt to be necessary by the Investigator and/or patient (e.g., intolerable injection site reactions).
In the event of an injection site reaction of Grade 3 and above, and/or if significant ulceration, tenderness or lymphadenopathy was observed, at the discretion of the Investigator, patients could be administered a half dose of the study drug (i.e., a single 0.05 mL intradermal injection of IMM-101) or the timing of the injection could be delayed. If the dosing interval was increased, the patient still attended the study site for safety assessments preferably every 3 months but, if this was not possible, every 6 months at a minimum. The blood sample for exploratory analysis continued to be taken every 6 months.
Any change in the dose of study drug administered or the frequency of dose administration was recorded in the patient's case report form (CRF). In the case of withdrawal, separate consent was sought to allow the continued collection on patient status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMM-101 | Experimental | Biological: IMM-101IMM-101 1.0 mg administered intradermally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient was previously enrolled in Study IMM-101-001
- Patient gave consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor
- Patient gave signed informed consent for participation in the study
Key exclusion criteria (5 listed)
- Female patient of child-bearing potential who was not, in the opinion of the Investigator, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]).
- Those patients that utilised hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) was discontinued from being used concomitantly with the hormonal contraception.
- Patient of non-child-bearing potential were defined as having 12 month amenorrhoea or were surgically sterile.
- Female patient who was pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
- Patient was unable or unwilling to comply with the protocol.
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 |
|---|---|---|
| IMM-101Also: Heat-killed whole cell M. obuenseIMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. | Biological | IMM-101 |
Primary outcome
Adverse Events With a Causal Relationship to IMM-101
Time frame: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. Treatment related Adverse Events were defined as being definitely, probably or possibly related to IMM-101 or with an unknown relationship.
Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3
Time frame: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities
Treatment Emergent Serious Adverse Events
Time frame: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. There were no IMM-101 related serious adverse events reported during the study.
2 secondary outcomes
Survival
Time frame: Overall survival was defined as the time from enrolment until date of death for up to 81 months. Patients still alive after 81 months were censored at withdrawal from the study or at last known date alive if later.
Incidence of Change in Metastatic Disease
Time frame: From Informed Consent to death or withdrawal (median 4.4 years, range 1.2 - 6.7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alberto Fusi, Dr principal investigator
St George's, University of London
1 site 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 IMM-101 in people with Malignant Melanoma, run by Immodulon Therapeutics Ltd at 1 site 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 3 inclusion and 5 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events With a Causal Relationship to IMM-101 (time frame: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).). 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 22 Jun 2023.