Advanced pancreatic cancer The overall objective of this clinical study is to evaluate a potential synergy between gemcitabine and IMM-101 and any beneficial effect this may have on safety and tolerability, QoL, clinical signs and symptoms of disease, disease outcome and selected markers of tumour burden and immunological status in patients with inoperable, locally advanced or metastatic pancreatic cancer. MedDRA version: 16.1 Level: LLT
Conditions
Interventions
Product Name: IMM-101
Product Code: Heat-killed whole cell Mycobaterium obuense
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Heat-
Sponsors
Immodulon Therapeutics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. WHO performance status of 0-2. Serum creatinine 3 months from randomisation. Provide written informed consent to participate as shown by a signature and date on the patient's informed consent form (ICF) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients will be ineligible if one or more of the following statements are applicable: Patient has acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas. Patient has severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments. Patient has been on any previous chemotherapy treatment for pancreatic cancer. Patient is eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation. Patient has clinical or CT evidence of central nervous system (CNS) metastases. Patient has 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 prior and there are no signs of recurrence. Patient has serum albumin 70 mg/L. Patient has had radiotherapy in the 6 weeks prior to screening. Patient has used depot corticosteroids in the 6 weeks prior to screening. Patient has had chronic use of any systemic corticosteroids (>10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) 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 (e.g. physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilise hormonal contraceptives must have used the same method for at least three months before study dosing. Patient of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile. Female patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (HCG) must be negative. Patient has been administered any investigational drug, vaccine or device in the 3 months prior to screening. Patient has a 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. Patient has presence of any uncontrolled concomitant disease (e.g. unstable angina pectoris, congestive heart failure, myocardial infarction, arrhythmias, 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. Patient has a history of serious adverse reaction or serious hypersensitivity to any drug. Patient has had any previous treatment with IMM-101 or related mycobacterial immunotherapy. Patient is 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. Patient is unable or unwilling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by: • Local and systemic toxicities. • Number, type and degree of toxicities as measured by the NCI CTCAE v4.0. • QoL (EORTC QLQ-C30 supplemented with EORTC QLQ-PAN26). ; Secondary Objective: A clinically relevant improvement in one or more markers of disease status and progression: • Overall survival (OS). • Progression-free survival (PFS). • Overall response rate (ORR). • Reduction in metastatic disease • Circulating levels of carbohydrate antigen 19.9 (CA19.9). • Circulating levels of carcinoembryonic antigen (CEA). • Nutritional status (weight, appetite, serum albumin). • Pain control and analgesic use. Exploratory endpoints may include: •A change in levels of circulating tumour cells consistent with a reduction or stabilisation of tumour burden. •A change in one or more markers of immune status based on cellular involvement or cytokine/immune mediator production. ; Primary end point(s): No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by: Local and systemic toxicities. Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0. QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire). ;Timepoint(s) of evaluation of this end point: After 6 months and 12 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A clinically relevant improvement in one or more markers of disease status and progression: • Overall survival (OS). • Progression-free survival (PFS). • Overall response rate (ORR). • Reduction in metastatic disease. • Circulating levels of carbohydrate antigen 19.9 (CA19.9). • Circulating levels of carcinoembryonic antigen (CEA). • Nutritional status (weight, appetite, serum albumin). • Pain control and analgesic use ;Timepoint(s) of evaluation of this end point: After 6 months and 12 months treatment | — |
Countries
Ireland, Italy, Spain, United Kingdom
Contacts
Public ContactClinical Trials Co-ordinator
Immodulon Therapeutics Ltd
Outcome results
None listed