Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 16, 2016
First Posted Date  ICMJE January 4, 2017
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
  • 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.
  • 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
  • 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
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Cancer
Intervention  ICMJE
  • 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
  • Drug: Capecitabine
    Standard of Care chemotherapy
  • 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
  • Biological: cetuximab
    Standard of Care immunotherapy
    Other Name: Erbitux
  • Biological: Anti-PD1
    Standard of Care immunotherapy
    Other Names:
    • pembrolizumab (KEYTRUDA),
    • nivolumab (OPDIVO)
  • Biological: Ipilimumab
    Standard of Care immunotherapy
    Other Name: YERVOY
  • Drug: Cyclophosphamide
    Standard of Care chemotherapy
    Other Name: cytophosphane
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
    • Drug: Nabpaclitaxel
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
    • Drug: Capecitabine
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Folinic Acid
    • Drug: Fluorouracil
    • Drug: Irinotecan
    • Drug: Oxaliplatin
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Folinic Acid
    • Drug: Fluorouracil
    • Drug: Oxaliplatin
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Folinic Acid
    • Drug: Fluorouracil
    • Drug: Irinotecan
    • Biological: cetuximab
  • 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.
    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
    • Drug: Nabpaclitaxel
  • 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.

    Interventions:
    • Biological: IMM-101
    • Biological: Anti-PD1
  • 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.
    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
  • 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.
    Interventions:
    • Biological: IMM-101
    • Biological: Anti-PD1
  • 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.
    Interventions:
    • Biological: IMM-101
    • Biological: Ipilimumab
  • 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.
    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
    • Drug: Nabpaclitaxel
  • 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.
    Interventions:
    • Biological: IMM-101
    • Drug: Gemcitabine
  • 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.

    Interventions:
    • Biological: IMM-101
    • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 8, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2016)
300
Actual Study Completion Date  ICMJE August 30, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03009058
Other Study ID Numbers  ICMJE IMM-101-011
2016 001459 28 ( EudraCT Number )
CANC 32085 ( Other Identifier: National Institute for Health Research (UK) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immodulon Therapeutics Ltd
Study Sponsor  ICMJE Immodulon Therapeutics Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Cunningham, MD FRCP Royal Marsden Hospital Foundation Trust
PRS Account Immodulon Therapeutics Ltd
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP