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Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (MODULATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03009058
Recruitment Status : Terminated (Commercial reasons)
First Posted : January 4, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Biological: IMM-101 Drug: Gemcitabine Drug: Nabpaclitaxel Drug: Capecitabine Drug: Folinic Acid Drug: Fluorouracil Drug: Irinotecan Drug: Oxaliplatin Biological: cetuximab Biological: Anti-PD1 Biological: Ipilimumab Drug: Cyclophosphamide Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR

Drug: Nabpaclitaxel
Standard of Care chemotherapy
Other Name: Abraxane
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR

Drug: Capecitabine
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Folinic Acid
Standard of Care chemotherapy
Other Name: Leucovorin

Drug: Fluorouracil
Standard of Care chemotherapy
Other Name: 5FU

Drug: Irinotecan
Standard of Care chemotherapy
Other Names:
  • Campto
  • Camptosar

Drug: Oxaliplatin
Standard of Care chemotherapy
Other Name: Eloxatin
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Folinic Acid
Standard of Care chemotherapy
Other Name: Leucovorin

Drug: Fluorouracil
Standard of Care chemotherapy
Other Name: 5FU

Drug: Oxaliplatin
Standard of Care chemotherapy
Other Name: Eloxatin
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Folinic Acid
Standard of Care chemotherapy
Other Name: Leucovorin

Drug: Fluorouracil
Standard of Care chemotherapy
Other Name: 5FU

Drug: Irinotecan
Standard of Care chemotherapy
Other Names:
  • Campto
  • Camptosar

Biological: cetuximab
Standard of Care immunotherapy
Other Name: Erbitux
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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR
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
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR

Drug: Nabpaclitaxel
Standard of Care chemotherapy
Other Name: Abraxane
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Biological: Anti-PD1
Standard of Care immunotherapy
Other Names:
  • pembrolizumab (KEYTRUDA),
  • nivolumab (OPDIVO)
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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR
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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Biological: Anti-PD1
Standard of Care immunotherapy
Other Names:
  • pembrolizumab (KEYTRUDA),
  • nivolumab (OPDIVO)
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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Biological: Ipilimumab
Standard of Care immunotherapy
Other Name: YERVOY
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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR

Drug: Nabpaclitaxel
Standard of Care chemotherapy
Other Name: Abraxane
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.
 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Gemcitabine
Standard of Care chemotherapy
Other Name: GEMZAR
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.

 Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Name: Heat killed M. obuense (NCTC) 13365)

Drug: Cyclophosphamide
Standard of Care chemotherapy
Other Name: cytophosphane


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009058


Locations
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France
Centre Léon Bérard, Dpt Medecine & INSERM
Lyon, France, 69373
Gustave Roussy Cancer Center
Villejuif, France, 94805
United Kingdom
St George's University of London, Institute of Infection and Immunity
London, United Kingdom, SW17 0RE
Royal Marsden Hospital Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Immodulon Therapeutics Ltd
Investigators
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Principal Investigator: David Cunningham, MD FRCP Royal Marsden Hospital Foundation Trust
More Information
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Responsible Party: Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT03009058    
Other Study ID Numbers: IMM-101-011
2016 001459 28 ( EudraCT Number )
CANC 32085 ( Other Identifier: National Institute for Health Research (UK) )
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immodulon Therapeutics Ltd:
Unresectable cancer
pancreatic
melanoma
breast
 lung
colorectal
cholangio
sarcoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Leucovorin
Folic Acid
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Pembrolizumab
Nivolumab
Capecitabine
Oxaliplatin
Irinotecan
 Fluorouracil
Cetuximab
Ipilimumab
Levoleucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors