- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03009058
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (MODULATE)
A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Lyon, France, 69373
- Centre Léon Bérard, Dpt Medecine & INSERM
-
Villejuif, France, 94805
- Gustave Roussy Cancer Center
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-
-
-
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London, United Kingdom, SW17 0RE
- St George's University of London, Institute of Infection and Immunity
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
|
Experimental: 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: IMM-101+FOLFOX colorectal cancer
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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: IMM-101+FOLFIRI+CETUXIMAB 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care immunotherapy
Other Names:
|
Experimental: 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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: IMM-101+anti-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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care immunotherapy
Other Names:
|
Experimental: 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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: IMM-101+anti-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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care immunotherapy
Other Names:
|
Experimental: IMM-101+ anti-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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care immunotherapy
Other Names:
|
Experimental: 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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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.
|
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
Experimental: 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. |
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
Standard of Care chemotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Initial assessment at Week 28
|
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
|
Initial assessment at Week 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Week 28 through study completion (maximum 4.5 years)
|
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
|
Week 28 through study completion (maximum 4.5 years)
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Number of participants with treatment-related adverse events when IMM-101 is given in combination with a checkpoint blockade inhibitor
Time Frame: Initial assessments at Week 12 and Week 28 then through study completion (maximum 4.5 years)
|
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
|
Initial assessments at Week 12 and Week 28 then through study completion (maximum 4.5 years)
|
Response to treatment
Time Frame: Initial assessment at Week 28 then through study completion (maximum 4.5 years)
|
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
|
Initial assessment at Week 28 then through study completion (maximum 4.5 years)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Cunningham, MD FRCP, Royal Marsden Hospital Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Neoplastic Processes
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Micronutrients
- Vitamins
- Immune Checkpoint Inhibitors
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Hematinics
- Gemcitabine
- Cyclophosphamide
- Fluorouracil
- Capecitabine
- Oxaliplatin
- Nivolumab
- Pembrolizumab
- Leucovorin
- Irinotecan
- Levoleucovorin
- Albumin-Bound Paclitaxel
- Folic Acid
- Ipilimumab
- Cetuximab
Other Study ID Numbers
- IMM-101-011
- 2016 001459 28 (EudraCT Number)
- CANC 32085 (Other Identifier: National Institute for Health Research (UK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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