Pleural malignant mesothelioma. MedDRA version: 20.0 Level: PT Classification code 10027407 Term: Mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: MesoPher
Pharmaceutical Form: Dispersion for injection/infusion
INN or Proposed INN: MesoPher
Current Sponsor code: MesoPher
Other descriptive name: MESOPHER
Concentration unit: U unit(s
Sponsors
Amphera B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be enrolled in this study only if they meet all of the following criteria: 1. Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study. 2. Subjects with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive (so CR, PR or SD) after 4 to 6 cycles with first line chemotherapy with antifolate/platinum (as determined by CT scanning). Subjects retreated with antifolate/platinum after a disease-free interval of 12 months after the first chemotherapeutic treatment are eligible. Concurrent bevacizumab during chemotherapy is allowed but patients who receive bevacizumab will only be eligible if they stop bevacizumab due to non-tolerance before or by the end of the chemotherapy period. Patients who benefit from bevacizumab use may continue treatment with bevacizumab and will consequently not be eligible for the study . 3. Subject must have signed informed consent within 8 weeks of their last chemo and the date of their informed consent must be such that all per protocol required procedures can be done in such a timeframe that the first treatment can be given within 9 and 13 weeks after their last chemotherapy. 4. Measurable disease has to be assessed by modified RECIST criteria on CT scanning by radiologic imaging. Even in the absence of measurable disease patients can be included in the study. In such case CT scanning will also be done to evaluate the disease. 5. Subjects must be at least 18 years old. 6. Subjects must have WHO-ECOG performance status of 0 or 1. 7. Subjects must have adequate organ function and adequate bone marrow reserve at screening: - creatinine = 1.5 × upper limit of normal [ULN] or glomerular filtration rate = 50mL/min - ALT, AST, bilirubin = 1.5 × ULN - Absolute neutrophil count =1.5 x 1000000000/L, platelet count =100 x 1000000000/L, and Hb =9.0g/dL. 8. 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. 9. 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. 10. Subjects must be willing and able to follow the protocol requirements and must be willing and able to return to the study center for adequate follow-up visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: Subjects will not be enrolled in this study if they meet any of the following criteria: 1. Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study. 2. Subject with any serious intercurrent chronic or acute illness such as cardiac (New York Heart Association [NYHA] Class III or IV) or hepatic disease or other serious concomitant disease considered by the investigator to constitute an unwarranted high risk for investigational dendritic cell treatment. 3. Subject with any known active serious infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus or syphilis infection. 4. Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor. 5. Subject who has received an organ allograft. 6. Subject with any previous 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 subject has been disease-free for at least 3 years. 7. Subject with a known allergy to shell fish (may contain KLH). 8. Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraceptive methods (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 12 months after the last study drug administration. 9. Subject with inadequate peripheral vein access to perform leukapheresis. 10. Use of >10 mg of steroids (or other immunosuppressive agents) during the past 6 weeks before the first study drug administration and throughout the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid </=10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 11. Treatment with any investigational product within 4 weeks or 5 half-lives (whichever is longer) before the first study drug administration or concomitant participation in another clinical study. 12. Subject who is unwilling or unable to follow the protocol requirements, including availability for follow-up assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the overall survival rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.;Secondary Objective: Secondary objectives: • to evaluate the overall survival rate at 12 and 18 months after randomization, in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone. • to evaluate progression free survival in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone. • to evaluate the overall response rate and duration of response in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone. • to evaluate quality of life in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone. • to evaluate the safety and tolerability of dendritic cell immunotherapy with MesoPher.;Primary end point(s): The primary endpoint of the study will be overall survival (OS). Overall survival will be determined as the time from randomization (about 3 to 4 months after diagnosis) until death. For subjects who are alive at the end of the study or lost to follow-up, OS will be censored on the last date when subjects are known to be alive.;Timepoint(s) of evaluation of this end point: End of study. Death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following efficacy endpoints are considered secondary: • Survival status at 12, and 18 months after randomization. • Progression-free survival (PFS), including symptomatic (clear evident signs of disease progression) progression-free survival. Progression free survival (PFS) will be determined by the local investigators from CT scans, using the modified RECIST criteria. The time of the first CT scan showing progression (i.e., time to progression) will define the end of the PFS. • Overall response rate and duration of response. Overall response rate is defined as the proportion of subjects with confirmed CR or PR according to the modified RECIST criteria (i.e. CR or PR that persist on repeat imaging performed >4 weeks after the initial documentation of response). Response to treatment will be determined at every CT scan. • The change in Quality of Life from baseline. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and its lung cancer (LC)-specific module EORTC QLQ - LC13 will be used to evaluate quality of life.;Timepoint(s) of evaluation of this end point: 12 and 18 months after randomisation | — |
Countries
Belgium, France, Netherlands, United Kingdom
Contacts
Public ContactIlona Enninga
Amphera B.V.
Outcome results
None listed