|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|(borderline) resectable pancreatic adenocarcinoma
|Medical condition in easily understood language
|resectable pancreatic cancer
|Diseases [C] - Cancer [C04]
|E.1.2 Medical condition or disease under investigation
|Pancreas carcinoma resectable
|System Organ Class
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|The main goal of this study is to determine the feasibility of administering MesoPher after standard of care therapy in patients with resected pancreatic cancer.
|Secondary objectives of the trial
|Secondly, we want to assess the toxicity and safety of MesoPher administration in surgically resected pancreatic cancer patients who received standard of care. In addition, to determine the systemic immune profile, with emphasis on T lymphocytes, and investigate how these immune profiles are affected by MesoPher for individual patients. In addition we want to investigate the efficacy of this DC vaccination treatment approach.
|Trial contains a sub-study
|Principal inclusion criteria
|• Surgically resected pancreatic cancer.
• Completed post-operative standard treatment. Patients who did not complete standard of care due to toxicity or who are not able to start standard of care due to specific reasons are allowed to participate in the study after approval of the coordinating investigator.
• No disease activity as assessed by radiological imaging.
• Patients must be at least 18 years old and must be able to give written informed consent.
• Patients must be ambulatory (WHO-ECOG performance status 0,1 or 2) and in stable medical condition.
• Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count >1.0 x 10E9/l, platelet count > 100 x 10E9/l, and Hb > 6.0 mmol/l (as determined during screening).
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test just prior to the first study drug administration on Day 1, and must be willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) or true abstinence (when this is in line with the preferred and usual lifestyle)* during the study and for at least 12 months after the last study drug administration. *True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Men must be willing to use an effective contraceptive method (e.g. condom, vasectomy) during the study and for at least 12 months after the last study drug administration.
• Positive DTH skin test (induration > 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid (see section 8.3 for DTH skin
• Ability to return to the hospital for adequate follow-up as required by this protocol.
• Written informed consent according to ICH-GCP.
|Principal exclusion criteria
|• Medical or psychological impediment to probable compliance with the protocol.
• Current or previous treatment with immunotherapeutic agents.
• Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6 weeks interval.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.
• Serious concomitant disease, or active infections.
• History of autoimmune disease or organ allografts (or with active acute or chronic infection, including HIV and viral hepatitis).
• Serious intercurrent chronic or acute illness such as pulmonary disease (asthma or COPD), cardiac disease (NYHA class III or IV), hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for investigational DC treatment.
• Known allergy to shell fish (may contain keyhole limpet hemocyanin (KLH).
• Pregnant or lactating women.
• Inadequate vein access to perform leukapheresis.
• Concomitant participation in another clinical trial (except participation in a biobank study).
• An organic brain syndrome or other significant psychiatric abnormality which would compromise the ability to give informed consent, and preclude participation in the full protocol and follow-up.
• Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessments.
|E.5 End points
|Primary end point(s)
|To determine the feasibility of administering MesoPher after standard of care adjuvant therapy in patients with resected pancreatic cancer.
|Timepoint(s) of evaluation of this end point
|Evaluation will take place after 10th patient (last patient of the standard cohort) completed the full study protocol.
|Secondary end point(s)
|To determine safety and tolerability in terms of AEs, laboratory data and vital signs.
To determine the systemic immune profile, with emphasis on T lymphocytes, and investigate how these immune profiles are affected by MesoPher for individual patients.
To determine efficacy by assessing the 1 year-recurrence free survival rate.
|Timepoint(s) of evaluation of this end point
|Evaluation will take place after last patient completed the full study protocol.
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Other scope of the trial description
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|The trial involves multiple Member States
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days