During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type. The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.
The study will consist of three phases - Screening, Treatment and Maintenance. Patients who provide informed consent, will participate in a Screening period of up to 28 days to establish eligibility. Once eligibility is confirmed, patients will enter the Treatment Phase of the study. In the Treatment Phase all patients will receive IMM-101 for 28 weeks. At Week 32, if the Investigator considers it in the patients' best interest patients will progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks (or as close to this interval as permitted due to practical or logistical considerations). Patients will be followed up for assessment of safety, response to treatment, survival, and immunological markers for up to 4.5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Standard of Care chemotherapy
Standard of Care chemotherapy
Centre Léon Bérard, Dpt Medecine & INSERM
Lyon, France
Gustave Roussy Cancer Center
Villejuif, France
St George's University of London, Institute of Infection and Immunity
London, United Kingdom
Royal Marsden Hospital Foundation Trust
London, United Kingdom
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions.
Time frame: Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
Time frame: Week 28 through study completion (maximum 4.5 years)
Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents
Time frame: From screening until study termination an average of 3 months.
Response to Treatment
Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator: * Immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions * Immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC * Immune-related Progressive Disease (irPD) is ≥25% increase in tumour burden from the lowest level recorded. * Everything else is considered immune-related Stable Disease (irSD).
Time frame: Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients
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Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care immunotherapy
Standard of Care immunotherapy
Standard of Care immunotherapy
Standard of Care chemotherapy
Overall Survival (OS)
Assessment of overall survival (defined as the time from enrolment to death due to any cause).
Time frame: From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.