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

First listed
Jan 4, 2017
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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