A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001
Patients who were previously enrolled in Study IMM-101-001 and who provide informed consent will be eligible to participate in this study.
Once eligibility is confirmed, a full medical history covering the period from their completion of Study IMM-101-001 to date will be taken.
The treatment regimen with IMM-101 will be one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval may be modified at the discretion of the Investigator provided the minimum period between doses in no less than 14 days.
The overall objective is to determine the long term safety profile of IMM-101 administered intradermally for extended use.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: 36 months ]Local and systemic toxicities Adverse events
- Efficacy [ Time Frame: 36 months ]Overall survival (OS). Progression-free survival (PFS). Reduction in metastatic disease.
- Exploratory [ Time Frame: 36 months ]
Blood samples will be collected and sera prepared for analysis of immunological markers and mediators.
Exploratory endpoints may include a change in one or more markers of immune status based on cellular involvement, function or cytokine/immune mediator production such as, for example, cytokines and antibodies, or any other clinically or immunologically relevant assays that may become pertinent during the course of the clinical trial.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
IMM-101 1.0 mg administered intradermally
IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
Other Name: Heat-killed whole cell M. obuense
This is an open-label long term follow up study. The study will consist of two phases:
- Screening and enrolment Patients, who provide informed consent, will participate in a screening period of up to 28 days to establish eligibility. Once eligibility is confirmed a full disease and treatment history covering the period from their completion of Study IMM-101 001 to date will be taken.
- Treatment Patients can 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 is contraindicated, the patient does not wish to continue or the study is terminated by the Sponsor. At no point should the elapsed period between IMM-101 doses be less than 14 days.
Patients may choose to withdraw from the study at any time and for any reason. IMM-101 should 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 is observed, at the discretion of the Investigator, patients may 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 may be delayed. If the dosing interval is increased, the patient should still attend the study site for safety assessments preferably every 3 months but, if this is not possible, every 6 months at a minimum. The blood sample for exploratory analysis should continue to be taken every 6 months.
Any change in the dose of study drug administered or the frequency of dose administration should be recorded in the patient's case report form (CRF). In the case of withdrawal, separate consent will be sought to allow the continued collection on patient status.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559818
|Advanced Therapy Centre, The London Clinic|
|London, United Kingdom|
|Principal Investigator:||Angus Dalgleish, Professor||St George's, University of London|