Metastatic Cancer
Conditions
Keywords
Unresectable cancer, pancreatic, melanoma, breast, lung, colorectal, cholangio, sarcoma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALIMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
DRUGGemcitabine
Standard of Care chemotherapy
DRUGNab-paclitaxel
Standard of Care chemotherapy
DRUGCapecitabine
Standard of Care chemotherapy
DRUGFolinic Acid
Standard of Care chemotherapy
DRUGFluorouracil
Standard of Care chemotherapy
DRUGIrinotecan
Standard of Care chemotherapy
DRUGOxaliplatin
Standard of Care chemotherapy
BIOLOGICALcetuximab
Standard of Care immunotherapy
BIOLOGICALAnti-PD1
Standard of Care immunotherapy
BIOLOGICALIpilimumab
Standard of Care immunotherapy
DRUGCyclophosphamide
Standard of Care chemotherapy
Sponsors
Immodulon Therapeutics Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic or unresectable cancer and considered by their physician to be indicated for a new line of SOC as listed in the protocol * Are ineligible for a disease specific clinical study with IMM-101 * Have an estimated life expectancy greater than 3 months (from Day 0) * Give signed informed consent for participation in the study * Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤2 at Day 0. * Have adequate bone marrow, hepatic and renal function
Exclusion criteria
* Patient has previously received treatment with IMM-101 * Patient is currently part way through a course of chemotherapy or immunotherapy * Patient is receiving concomitant treatment with another investigational product * Patient has received an investigational drug within the 4 weeks prior to IMM 101 administration * Patient has significant cardiovascular disease * Patient has any previous or concurrent malignancy (excluding adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence) * Patient has co existing active infection or medical condition which will substantially increase the risk associated with the patient's participation in the study * Patient has uncontrolled hypercalcaemia * Patient has previously experienced an allergic reaction to any mycobacterial product. * The patient has a history of non-infectious pneumonitis that required steroids or current pneumonitis * Patient has received live vaccine within 30 days of planned start of study medication * Patient is pregnant or a breast feeding woman. * Patient is unwilling to use a medically acceptable, effective method of contraception throughout the treatment period and for at least 6 months after discontinuation of treatment. * Patient has used depot corticosteroids in the 6 weeks before initiation of Screening * Patient has had chronic use of systemic corticosteroids within the 2 week period before the first administration of IMM-101 * Patient has received a blood transfusion within 4 weeks prior to Screening * In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months. | Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Week 28 through study completion (maximum 4.5 years) | Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions. |
| Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor | From screening until study termination an average of 3 months. | 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 |
| Response to Treatment | 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 | 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). |
| Overall Survival (OS) | 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. | Assessment of overall survival (defined as the time from enrolment to death due to any cause). |
Countries
France, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMM-101 in Combination With Anti PDL1 in Melanoma Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death-1 (PD-1) agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated soon after initiation for commercial reasons | 2 |
Baseline characteristics
| Characteristic | IMM-101 in Combination With Anti PDL1 in Melanoma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 70 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United Kingdom | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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.
Population: Both patients were assessed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IMM-101 in Combination With Anti PDL1 in Melanoma | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 Participants |
Secondary
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)
Population: Study was terminated before the Week 28 timepoint was reached.
Secondary
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.
Population: Both patients enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IMM-101 in Combination With Anti PDL1 in Melanoma | Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor | 1 Participants |
Secondary
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.
Population: Assessment of overall survival (defined as the time from enrolment to death due to any cause). However, whilst 2 participants were monitored and analyzed, neither patient died before the study was terminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IMM-101 in Combination With Anti PDL1 in Melanoma | Overall Survival (OS) | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IMM-101 in Combination With Anti PDL1 in Melanoma | Response to Treatment | immune related Stable Disease [irSD] | 1 Participants |
| IMM-101 in Combination With Anti PDL1 in Melanoma | Response to Treatment | immune related Partial Response [irPR] | 1 Participants |
| IMM-101 in Combination With Anti PDL1 in Melanoma | Response to Treatment | immune related Complete Response [irCR] | 0 Participants |