Study on dendritic cell therapy as maintenance therapy for patients that have been treated for Mesothelioma.

Phase 1

• Conditions: Pleural malignant mesothelioma.; MedDRA version: 20.0Level: PTClassification code 10027407Term: Mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001774-41-NL
• Lead Sponsor: Amphera B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-14
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

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 and during the first 6 weeks after completion of chemotherapy is allowed.
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. In case disease is not measurable by modified RECIST criteria, RECIST 1.1 is acceptable. 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 during the study and for at least 3 months after the last study drug administration. 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 (eg, condom, vasectomy) during the study and for at least 3 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 230
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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 3 months after the last study drug administration.
9. Men unwilling to use effective contraception for the duration of the study and for at least 3 months after the last study drug administration.
10. Subject with inadequate peripheral vein access to perform leukapheresis.
11. 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 12. 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.
13. Subject who is unwilling or unable to follow the protocol requirements, including availability for follow-up assessment.
14. Patients who have a PD during the 4-6 cycles of chemotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified