<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009058</url>
  </required_header>
  <id_info>
    <org_study_id>IMM-101-011</org_study_id>
    <secondary_id>2016 001459 28</secondary_id>
    <secondary_id>CANC 32085</secondary_id>
    <nct_id>NCT03009058</nct_id>
  </id_info>
  <brief_title>Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer</brief_title>
  <acronym>MODULATE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immodulon Therapeutics Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immodulon Therapeutics Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During this open label study patients will receive IMM-101 in conjunction with a recognised&#xD;
      standard of care for metastatic or unresectable cancer for the patient's specific tumour&#xD;
      type.&#xD;
&#xD;
      The primary objective of the study is to provide safety data for IMM-101 in combination with&#xD;
      a number of selected standard of care regimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of three phases - Screening, Treatment and Maintenance. Patients who&#xD;
      provide informed consent, will participate in a Screening period of up to 28 days to&#xD;
      establish eligibility. Once eligibility is confirmed, patients will enter the Treatment Phase&#xD;
      of the study.&#xD;
&#xD;
      In the Treatment Phase all patients will receive IMM-101 for 28 weeks.&#xD;
&#xD;
      At Week 32, if the Investigator considers it in the patients' best interest patients will&#xD;
      progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks&#xD;
      (or as close to this interval as permitted due to practical or logistical considerations).&#xD;
      Patients will be followed up for assessment of safety, response to treatment, survival, and&#xD;
      immunological markers for up to 4.5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Commercial reasons&#xD;
  </why_stopped>
  <start_date type="Actual">May 24, 2017</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>Initial assessment at Week 28</time_frame>
    <description>Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>Week 28 through study completion (maximum 4.5 years)</time_frame>
    <description>Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events when IMM-101 is given in combination with a checkpoint blockade inhibitor</measure>
    <time_frame>Initial assessments at Week 12 and Week 28 then through study completion (maximum 4.5 years)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to treatment</measure>
    <time_frame>Initial assessment at Week 28 then through study completion (maximum 4.5 years)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <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</time_frame>
  </secondary_outcome>
  <number_of_arms>17</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>IMM-101 + Gem panc ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem/nab-paclitaxel panc ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem+capecitabine panc ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with gemcitabine +capecitabine combination therapy.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101 + FOLFIRINOX panc ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan and OXaliplatin) treatment.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+FOLFOX colorectal cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard FOLFOX (FOLinic acid, Fluorouracil and OXaliplatin) treatment.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+FOLFIRI+CETUXIMAB CRC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard FOLFIRI (FOLinic acid, Fluorouracil and IRInotecan) + cetuximab combination treatment.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem cholangio</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem lung ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem + nab-paclitaxel lung ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+anti-PD1 lung ca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem melanoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+anti-PD1 melanoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+ anti-CTLA-4 melanoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+Gem/ nab-paclitaxel breast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101 + Gem sarcoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMM-101+cyclophosphamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMM-101 will be given in combination with low dose cyclophosphamide (300mg/m2 in patients with solid malignancies.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IMM-101</intervention_name>
    <description>A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365</description>
    <arm_group_label>IMM-101 + FOLFIRINOX panc ca</arm_group_label>
    <arm_group_label>IMM-101 + Gem panc ca</arm_group_label>
    <arm_group_label>IMM-101 + Gem sarcoma</arm_group_label>
    <arm_group_label>IMM-101+ anti-CTLA-4 melanoma</arm_group_label>
    <arm_group_label>IMM-101+FOLFIRI+CETUXIMAB CRC</arm_group_label>
    <arm_group_label>IMM-101+FOLFOX colorectal cancer</arm_group_label>
    <arm_group_label>IMM-101+Gem + nab-paclitaxel lung ca</arm_group_label>
    <arm_group_label>IMM-101+Gem breast cancer</arm_group_label>
    <arm_group_label>IMM-101+Gem cholangio</arm_group_label>
    <arm_group_label>IMM-101+Gem lung ca</arm_group_label>
    <arm_group_label>IMM-101+Gem melanoma</arm_group_label>
    <arm_group_label>IMM-101+Gem+capecitabine panc ca</arm_group_label>
    <arm_group_label>IMM-101+Gem/ nab-paclitaxel breast</arm_group_label>
    <arm_group_label>IMM-101+Gem/nab-paclitaxel panc ca</arm_group_label>
    <arm_group_label>IMM-101+anti-PD1 lung ca</arm_group_label>
    <arm_group_label>IMM-101+anti-PD1 melanoma</arm_group_label>
    <arm_group_label>IMM-101+cyclophosphamide</arm_group_label>
    <other_name>Heat killed M. obuense (NCTC) 13365)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101 + Gem panc ca</arm_group_label>
    <arm_group_label>IMM-101 + Gem sarcoma</arm_group_label>
    <arm_group_label>IMM-101+Gem + nab-paclitaxel lung ca</arm_group_label>
    <arm_group_label>IMM-101+Gem breast cancer</arm_group_label>
    <arm_group_label>IMM-101+Gem cholangio</arm_group_label>
    <arm_group_label>IMM-101+Gem lung ca</arm_group_label>
    <arm_group_label>IMM-101+Gem melanoma</arm_group_label>
    <arm_group_label>IMM-101+Gem+capecitabine panc ca</arm_group_label>
    <arm_group_label>IMM-101+Gem/ nab-paclitaxel breast</arm_group_label>
    <arm_group_label>IMM-101+Gem/nab-paclitaxel panc ca</arm_group_label>
    <other_name>GEMZAR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nabpaclitaxel</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101+Gem + nab-paclitaxel lung ca</arm_group_label>
    <arm_group_label>IMM-101+Gem/ nab-paclitaxel breast</arm_group_label>
    <arm_group_label>IMM-101+Gem/nab-paclitaxel panc ca</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101+Gem+capecitabine panc ca</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folinic Acid</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101 + FOLFIRINOX panc ca</arm_group_label>
    <arm_group_label>IMM-101+FOLFIRI+CETUXIMAB CRC</arm_group_label>
    <arm_group_label>IMM-101+FOLFOX colorectal cancer</arm_group_label>
    <other_name>Leucovorin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101 + FOLFIRINOX panc ca</arm_group_label>
    <arm_group_label>IMM-101+FOLFIRI+CETUXIMAB CRC</arm_group_label>
    <arm_group_label>IMM-101+FOLFOX colorectal cancer</arm_group_label>
    <other_name>5FU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101 + FOLFIRINOX panc ca</arm_group_label>
    <arm_group_label>IMM-101+FOLFIRI+CETUXIMAB CRC</arm_group_label>
    <other_name>Campto</other_name>
    <other_name>Camptosar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101 + FOLFIRINOX panc ca</arm_group_label>
    <arm_group_label>IMM-101+FOLFOX colorectal cancer</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>cetuximab</intervention_name>
    <description>Standard of Care immunotherapy</description>
    <arm_group_label>IMM-101+FOLFIRI+CETUXIMAB CRC</arm_group_label>
    <other_name>Erbitux</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Anti-PD1</intervention_name>
    <description>Standard of Care immunotherapy</description>
    <arm_group_label>IMM-101+anti-PD1 lung ca</arm_group_label>
    <arm_group_label>IMM-101+anti-PD1 melanoma</arm_group_label>
    <other_name>pembrolizumab (KEYTRUDA),</other_name>
    <other_name>nivolumab (OPDIVO)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Standard of Care immunotherapy</description>
    <arm_group_label>IMM-101+ anti-CTLA-4 melanoma</arm_group_label>
    <other_name>YERVOY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Standard of Care chemotherapy</description>
    <arm_group_label>IMM-101+cyclophosphamide</arm_group_label>
    <other_name>cytophosphane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic or unresectable cancer and considered by their physician to be indicated&#xD;
             for a new line of SOC as listed in the protocol&#xD;
&#xD;
          -  Are ineligible for a disease specific clinical study with IMM-101&#xD;
&#xD;
          -  Have an estimated life expectancy greater than 3 months (from Day 0)&#xD;
&#xD;
          -  Give signed informed consent for participation in the study&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO)&#xD;
             Performance Status of ≤2 at Day 0.&#xD;
&#xD;
          -  Have adequate bone marrow, hepatic and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has previously received treatment with IMM-101&#xD;
&#xD;
          -  Patient is currently part way through a course of chemotherapy or immunotherapy&#xD;
&#xD;
          -  Patient is receiving concomitant treatment with another investigational product&#xD;
&#xD;
          -  Patient has received an investigational drug within the 4 weeks prior to IMM 101&#xD;
             administration&#xD;
&#xD;
          -  Patient has significant cardiovascular disease&#xD;
&#xD;
          -  Patient has any previous or concurrent malignancy (excluding adequately treated&#xD;
             carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma&#xD;
             skin cancer, or if previous malignancy was more than 5 years prior to Screening and&#xD;
             there are no signs of recurrence)&#xD;
&#xD;
          -  Patient has co existing active infection or medical condition which will substantially&#xD;
             increase the risk associated with the patient's participation in the study&#xD;
&#xD;
          -  Patient has uncontrolled hypercalcaemia&#xD;
&#xD;
          -  Patient has previously experienced an allergic reaction to any mycobacterial product.&#xD;
&#xD;
          -  The patient has a history of non-infectious pneumonitis that required steroids or&#xD;
             current pneumonitis&#xD;
&#xD;
          -  Patient has received live vaccine within 30 days of planned start of study medication&#xD;
&#xD;
          -  Patient is pregnant or a breast feeding woman.&#xD;
&#xD;
          -  Patient is unwilling to use a medically acceptable, effective method of contraception&#xD;
             throughout the treatment period and for at least 6 months after discontinuation of&#xD;
             treatment.&#xD;
&#xD;
          -  Patient has used depot corticosteroids in the 6 weeks before initiation of Screening&#xD;
&#xD;
          -  Patient has had chronic use of systemic corticosteroids within the 2 week period&#xD;
             before the first administration of IMM-101&#xD;
&#xD;
          -  Patient has received a blood transfusion within 4 weeks prior to Screening&#xD;
&#xD;
          -  In the opinion of the Investigator, the patient is unable or unwilling to comply with&#xD;
             the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Cunningham, MD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden Hospital Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Léon Bérard, Dpt Medecine &amp; INSERM</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy Cancer Center</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's University of London, Institute of Infection and Immunity</name>
      <address>
        <city>London</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Unresectable cancer</keyword>
  <keyword>pancreatic</keyword>
  <keyword>melanoma</keyword>
  <keyword>breast</keyword>
  <keyword>lung</keyword>
  <keyword>colorectal</keyword>
  <keyword>cholangio</keyword>
  <keyword>sarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Levoleucovorin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 31, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009058
org study id: IMM-101-011
secondary id: 2016 001459 28
secondary id: CANC 32085
nct id: NCT03009058
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: Initial assessment at Week 28
description: Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
measure: 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)
description: Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
measure: 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)
description: 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
measure: Response to treatment
time frame: Initial assessment at Week 28 then through study completion (maximum 4.5 years)
description: 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
measure: 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
arm group label: IMM-101 + Gem panc ca
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem/nab-paclitaxel panc ca
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem+capecitabine panc ca
arm group type: Experimental
description: 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.
arm group label: IMM-101 + FOLFIRINOX panc ca
arm group type: Experimental
description: 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.
arm group label: IMM-101+FOLFOX colorectal cancer
arm group type: Experimental
description: 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.
arm group label: IMM-101+FOLFIRI+CETUXIMAB CRC
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem cholangio
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem lung ca
arm group type: Experimental
description: 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
arm group label: IMM-101+Gem + nab-paclitaxel lung ca
arm group type: Experimental
description: 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.
arm group label: IMM-101+anti-PD1 lung ca
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem melanoma
arm group type: Experimental
description: 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.
arm group label: IMM-101+anti-PD1 melanoma
arm group type: Experimental
description: 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.
arm group label: IMM-101+ anti-CTLA-4 melanoma
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem breast cancer
arm group type: Experimental
description: 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.
arm group label: IMM-101+Gem/ nab-paclitaxel breast
arm group type: Experimental
description: 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.
arm group label: IMM-101 + Gem sarcoma
arm group type: Experimental
description: 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.
arm group label: IMM-101+cyclophosphamide
arm group type: Experimental
description: 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.
intervention type: Biological
intervention name: IMM-101
description: A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
arm group label: IMM-101 + FOLFIRINOX panc ca
arm group label: IMM-101 + Gem panc ca
arm group label: IMM-101 + Gem sarcoma
arm group label: IMM-101+ anti-CTLA-4 melanoma
arm group label: IMM-101+FOLFIRI+CETUXIMAB CRC
arm group label: IMM-101+FOLFOX colorectal cancer
arm group label: IMM-101+Gem + nab-paclitaxel lung ca
arm group label: IMM-101+Gem breast cancer
arm group label: IMM-101+Gem cholangio
arm group label: IMM-101+Gem lung ca
arm group label: IMM-101+Gem melanoma
arm group label: IMM-101+Gem+capecitabine panc ca
arm group label: IMM-101+Gem/ nab-paclitaxel breast
arm group label: IMM-101+Gem/nab-paclitaxel panc ca
arm group label: IMM-101+anti-PD1 lung ca
arm group label: IMM-101+anti-PD1 melanoma
arm group label: IMM-101+cyclophosphamide
other name: Heat killed M. obuense (NCTC) 13365)
intervention type: Drug
intervention name: Gemcitabine
description: Standard of Care chemotherapy
arm group label: IMM-101 + Gem panc ca
arm group label: IMM-101 + Gem sarcoma
arm group label: IMM-101+Gem + nab-paclitaxel lung ca
arm group label: IMM-101+Gem breast cancer
arm group label: IMM-101+Gem cholangio
arm group label: IMM-101+Gem lung ca
arm group label: IMM-101+Gem melanoma
arm group label: IMM-101+Gem+capecitabine panc ca
arm group label: IMM-101+Gem/ nab-paclitaxel breast
arm group label: IMM-101+Gem/nab-paclitaxel panc ca
other name: GEMZAR
intervention type: Drug
intervention name: Nabpaclitaxel
description: Standard of Care chemotherapy
arm group label: IMM-101+Gem + nab-paclitaxel lung ca
arm group label: IMM-101+Gem/ nab-paclitaxel breast
arm group label: IMM-101+Gem/nab-paclitaxel panc ca
other name: Abraxane
intervention type: Drug
intervention name: Capecitabine
description: Standard of Care chemotherapy
arm group label: IMM-101+Gem+capecitabine panc ca
intervention type: Drug
intervention name: Folinic Acid
description: Standard of Care chemotherapy
arm group label: IMM-101 + FOLFIRINOX panc ca
arm group label: IMM-101+FOLFIRI+CETUXIMAB CRC
arm group label: IMM-101+FOLFOX colorectal cancer
other name: Leucovorin
intervention type: Drug
intervention name: Fluorouracil
description: Standard of Care chemotherapy
arm group label: IMM-101 + FOLFIRINOX panc ca
arm group label: IMM-101+FOLFIRI+CETUXIMAB CRC
arm group label: IMM-101+FOLFOX colorectal cancer
other name: 5FU
intervention type: Drug
intervention name: Irinotecan
description: Standard of Care chemotherapy
arm group label: IMM-101 + FOLFIRINOX panc ca
arm group label: IMM-101+FOLFIRI+CETUXIMAB CRC
other name: Campto
other name: Camptosar
intervention type: Drug
intervention name: Oxaliplatin
description: Standard of Care chemotherapy
arm group label: IMM-101 + FOLFIRINOX panc ca
arm group label: IMM-101+FOLFOX colorectal cancer
other name: Eloxatin
intervention type: Biological
intervention name: cetuximab
description: Standard of Care immunotherapy
arm group label: IMM-101+FOLFIRI+CETUXIMAB CRC
other name: Erbitux
intervention type: Biological
intervention name: Anti-PD1
description: Standard of Care immunotherapy
arm group label: IMM-101+anti-PD1 lung ca
arm group label: IMM-101+anti-PD1 melanoma
other name: pembrolizumab (KEYTRUDA),
other name: nivolumab (OPDIVO)
intervention type: Biological
intervention name: Ipilimumab
description: Standard of Care immunotherapy
arm group label: IMM-101+ anti-CTLA-4 melanoma
other name: YERVOY
intervention type: Drug
intervention name: Cyclophosphamide
description: Standard of Care chemotherapy
arm group label: IMM-101+cyclophosphamide
other name: cytophosphane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Cunningham, MD FRCP
role: Principal Investigator
affiliation: Royal Marsden Hospital Foundation Trust
facility: 
facility: 
facility: 
facility: 
country: France
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Leucovorin
mesh term: Folic Acid
mesh term: Cyclophosphamide
mesh term: Gemcitabine
mesh term: Pembrolizumab
mesh term: Fluorouracil
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Nivolumab
mesh term: Irinotecan
mesh term: Cetuximab
mesh term: Ipilimumab
mesh term: Albumin-Bound Paclitaxel
mesh term: Levoleucovorin
sharing ipd: No
submitted: March 31, 2023