Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
NCT ID: NCT03009058
Last Updated: 2024-11-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2017-05-31
2017-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMM-101 + Gem panc ca
IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
IMM-101+Gem/nab-paclitaxel panc ca
IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.
The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
Nab-paclitaxel
Standard of Care chemotherapy
IMM-101+Gem+capecitabine panc ca
IMM-101 will be given in combination with gemcitabine + capecitabine combination therapy.
The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
Capecitabine
Standard of Care chemotherapy
IMM-101 + FOLFIRINOX panc ca
IMM-101 will be given in combination with standard FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan and OXaliplatin) treatment.
The treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Folinic Acid
Standard of Care chemotherapy
Fluorouracil
Standard of Care chemotherapy
Irinotecan
Standard of Care chemotherapy
Oxaliplatin
Standard of Care chemotherapy
IMM-101+FOLFOX colorectal cancer (CRC)
IMM-101 will be given in combination with standard FOLFOX (FOLinic acid, Fluorouracil and OXaliplatin) treatment.
The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Folinic Acid
Standard of Care chemotherapy
Fluorouracil
Standard of Care chemotherapy
Oxaliplatin
Standard of Care chemotherapy
IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)
IMM-101 will be given in combination with standard FOLFIRI (FOLinic acid, Fluorouracil and IRInotecan) + cetuximab combination treatment.
The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Folinic Acid
Standard of Care chemotherapy
Fluorouracil
Standard of Care chemotherapy
Irinotecan
Standard of Care chemotherapy
cetuximab
Standard of Care immunotherapy
IMM-101+Gem cholangio
IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
IMM-101+Gem lung ca
IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
IMM-101+Gem + nab-paclitaxel lung ca
IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.
The treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
Nab-paclitaxel
Standard of Care chemotherapy
IMM-101+ anti-programmed death-1 (PD1) lung ca
IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab.
In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Anti-PD1
Standard of Care immunotherapy
IMM-101+Gem melanoma
IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
IMM-101+ anti-programmed death-1 (PD1) melanoma
IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. The first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Anti-PD1
Standard of Care immunotherapy
IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma
IMM-101 will be given in combination with standard treatment with ipilimumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the ipilimumab cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Ipilimumab
Standard of Care immunotherapy
IMM-101+Gem breast cancer
IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
IMM-101+Gem/ nab-paclitaxel breast
IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.
The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
Nab-paclitaxel
Standard of Care chemotherapy
IMM-101 + Gem sarcoma
IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
IMM-101+cyclophosphamide
IMM-101 will be given in combination with low dose cyclophosphamide (300mg/m2 in patients with solid malignancies.
The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Cyclophosphamide
Standard of Care chemotherapy
Interventions
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IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Gemcitabine
Standard of Care chemotherapy
Nab-paclitaxel
Standard of Care chemotherapy
Capecitabine
Standard of Care chemotherapy
Folinic Acid
Standard of Care chemotherapy
Fluorouracil
Standard of Care chemotherapy
Irinotecan
Standard of Care chemotherapy
Oxaliplatin
Standard of Care chemotherapy
cetuximab
Standard of Care immunotherapy
Anti-PD1
Standard of Care immunotherapy
Ipilimumab
Standard of Care immunotherapy
Cyclophosphamide
Standard of Care chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Immodulon Therapeutics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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David Cunningham, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden Hospital Foundation Trust
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016 001459 28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CANC 32085
Identifier Type: OTHER
Identifier Source: secondary_id
IMM-101-011
Identifier Type: -
Identifier Source: org_study_id
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