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:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]Local and systemic toxicities Adverse events
- Efficacy [ Time Frame: 36 months ] [ Designated as safety issue: No ]Overall survival (OS). Progression-free survival (PFS). Reduction in metastatic disease.
- Exploratory [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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 Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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
|Advanced Therapy Centre, The London Clinic|
|London, United Kingdom|
|Principal Investigator:||Angus Dalgleish, Professor||St George's, University of London|