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History of Changes for Study: NCT03009058
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (MODULATE)
Latest version (submitted August 8, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 30, 2016 None (earliest Version on record)
2 May 19, 2017 Recruitment Status, Study Status, Oversight and Contacts/Locations
3 June 6, 2017 Recruitment Status, Study Status and Contacts/Locations
4 June 12, 2017 Study Status
5 September 1, 2017 Recruitment Status and Study Status
6 August 8, 2018 Study Design and Study Status
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Study NCT03009058
Submitted Date:  December 30, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: IMM-101-011
Brief Title: Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (MODULATE)
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
Secondary IDs: 2016 001459 28 [EudraCT Number]
CANC 32085 [National Institute for Health Research (UK)]
Open or close this module Study Status
Record Verification: December 2016
Overall Status: Not yet recruiting
Study Start: January 2017
Primary Completion: January 2019 [Anticipated]
Study Completion: June 2022 [Anticipated]
First Submitted: December 16, 2016
First Submitted that
Met QC Criteria:
December 30, 2016
First Posted: January 4, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 30, 2016
Last Update Posted: January 4, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Immodulon Therapeutics Ltd
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Metastatic Cancer
Keywords: Unresectable cancer
pancreatic
melanoma
breast
lung
colorectal
cholangio
sarcoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 17
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Nabpaclitaxel
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Folinic Acid
Standard of Care chemotherapy
Other Names:
  • Leucovorin
Drug: Fluorouracil
Standard of Care chemotherapy
Other Names:
  • 5FU
Drug: Irinotecan
Standard of Care chemotherapy
Other Names:
  • Campto
  • Camptosar
Drug: Oxaliplatin
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Folinic Acid
Standard of Care chemotherapy
Other Names:
  • Leucovorin
Drug: Fluorouracil
Standard of Care chemotherapy
Other Names:
  • 5FU
Drug: Oxaliplatin
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Folinic Acid
Standard of Care chemotherapy
Other Names:
  • Leucovorin
Drug: Fluorouracil
Standard of Care chemotherapy
Other Names:
  • 5FU
Drug: Irinotecan
Standard of Care chemotherapy
Other Names:
  • Campto
  • Camptosar
Biological: cetuximab
Standard of Care immunotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Nabpaclitaxel
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Biological: Ipilimumab
Standard of Care immunotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Nabpaclitaxel
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • 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 Names:
  • Heat killed M. obuense (NCTC) 13365)
Drug: Cyclophosphamide
Standard of Care chemotherapy
Other Names:
  • cytophosphane
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: David Cunningham, MD FRCP
Telephone: 0044 207 808 2123
Email: ProfDavid.Cunningham@rmh.nhs.uk
Central Contact Backup: Ilda Guimarey
Telephone: 0044 020 3137 6346
Email: info@immodulon.com
Study Officials: David Cunningham, MD FRCP
Principal Investigator
Royal Marsden Hospital Foundation Trust
Locations: France
Centre Léon Bérard, Dpt Medecine & INSERM
Lyon, France, 69373
Contact:Contact: Jean-Yves Blay, Professor 0033 0478 785126 jean-yves.blay@lyon.unicancer.fr
Gustave Roussy Cancer Center
Villejuif, France, 94805
Contact:Contact: Aurélien Marabelle, Dr 0033 0142 115592 aurelien.marabelle@gustaveroussy.fr
United Kingdom
St George's University of London, Institute of Infection and Immunity
London, United Kingdom, SW17 0RE
Contact:Contact: Angus Dalgliesh, MD, FRACP, 0044 208 725 0809 dalgleis@sgul.ac.uk
Royal Marsden Hospital Foundation Trust
London, United Kingdom, SW3 6JJ
Contact:Contact: David Cunningham, MD, FRACP 0044 207 808 2123 ProfDavid.Cunningham@rmh.nhs.uk
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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