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

Sponsor
Immodulon Therapeutics Ltd
Study ID
NCT03009058
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMM-101 — BIOLOGICAL
    A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
  • Gemcitabine — DRUG
    Standard of Care chemotherapy
  • Nab-paclitaxel — DRUG
    Standard of Care chemotherapy
  • Capecitabine — DRUG
    Standard of Care chemotherapy
  • Folinic Acid — DRUG
    Standard of Care chemotherapy
  • Fluorouracil — DRUG
    Standard of Care chemotherapy
  • Irinotecan — DRUG
    Standard of Care chemotherapy
  • Oxaliplatin — DRUG
    Standard of Care chemotherapy
  • cetuximab — BIOLOGICAL
    Standard of Care immunotherapy
  • Anti-PD1 — BIOLOGICAL
    Standard of Care immunotherapy
  • Ipilimumab — BIOLOGICAL
    Standard of Care immunotherapy
  • Cyclophosphamide — DRUG
    Standard of Care chemotherapy

Study Details

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.

Key Dates

Start date
May 31, 2017
Status verified
Oct 2024
Primary completion
Aug 30, 2017
Completion
Aug 30, 2017

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: 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.
  • Experimental: 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.
  • 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.
  • 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
  • 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.
  • Experimental: 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.
  • 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.
  • Experimental: 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.
  • Experimental: 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months. ]

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