A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
Condition: Advanced Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: IMM-101; Gemcitabine
Intervention description: IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL) will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.
Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine.; Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks.
Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).
Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol.
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in
      combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL),
      clinical signs and symptoms of disease, selected markers of tumour burden and immunological
      status, and disease outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female; aged ≥18 years.

          -  Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the
             pancreas, including the mucinous variant. This will include locally advanced and
             metastatic disease (stage III/IV).

          -  Presence of measurable lesions in at least one site which have not been previously
             irradiated (bone lesions, ascites and pleural effusions are not considered as
             measurable), described as any of the following:

               -  Any primary tumour with at least bi-dimensionally measurable disease.

               -  a) Palpable lymph nodes; b) Deep seated lymph nodes.

               -  Liver metastases measurable by computerised tomography (CT) scan.

               -  Deep seated soft tissue lesions measurable by CT scan.

          -  World Health Organization (WHO) performance status of 0-2

          -  Serum creatinine <140 μmol/L

          -  White blood cell (WBC) count, including differential counts within the normal range
             or, if outside the normal range, considered by the Investigator not to be clinically
             significant.

          -  Life expectancy of >3 months from randomisation.

          -  Provided written informed consent to participate as shown by a signature and date on
             the patient's Informed Consent Form

        Exclusion Criteria:

          -  Acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas.

          -  Severe, active uncontrolled infection requiring systemic antibiotics, antiviral or
             antifungal treatments.

          -  Any previous chemotherapy treatment for pancreatic cancer.

          -  Eligible for resection of the pancreatic primary tumour but has either refused the
             operation or is considered to be medically unfit for the operation.

          -  Clinical or CT evidence of central nervous system (CNS) metastases.

          -  Any previous or concurrent malignancy, except 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 earlier and there were no signs of
             recurrence.

          -  Any previous treatment with IMM-101 or related mycobacterial immunotherapy.

          -  Serum albumin < 26 g/L.

          -  C-reactive protein (CRP) > 70 mg/L.

          -  Radiotherapy in the 6 weeks prior to screening.

          -  Depot corticosteroids in the 6 weeks prior to screening.

          -  Chronic use of any systemic corticosteroids and/or immunosuppressant drugs within the
             2-week period prior to the first administration of study drug.

          -  Female patient of child-bearing potential who is not, in the opinion of the
             Investigator, using an approved method of birth control.

          -  Female patient who were pregnant, breast feeding or planning a pregnancy during the
             course of the study. A pre-treatment serum pregnancy test measuring human chorionic
             gonadotrophin (hCG) had to be negative.

          -  Had been administered any investigational product e.g. drug, vaccine or device, in the
             3 months prior to screening.

          -  Surgical or medical condition which, in the judgement of the Investigator, might
             interfere with the activity of IMM-101, or with the performance of this study.

          -  Any uncontrolled concomitant disease (e.g. unstable angina pectoris, congestive heart
             failure, myocardial infarction, arrhythmias, and uncontrolled severe hypertension)
             which, in the judgement of the Investigator, might interfere with the activity of IMM
             101, or with the performance of this study.

          -  A history of serious adverse reaction or serious hypersensitivity to any drug.

          -  Known to have a history of human immunodeficiency virus (HIV) or syphilis, current
             symptomatic Hepatitis B or C. Testing is not required in the absence of clinical signs
             and symptoms suggestive of infection with HIV.

          -  Unable or unwilling to comply with the protocol.