Patients with metastatic colorectal carcinoma (CRC), who have undergone a complete resection of their primary tumor and recent resection of their liver metastases (R0 or R1) with curative intent. MedDRA version: 19.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: L-BLP25
Product Code: EMD531444
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: not available
Other descriptive name: L-BLP25 reconstituted
Concentration un
Sponsors
Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. Male or female. 3. At least 18 years of age. 4. Female patients of childbearing potential (and if appropriate male patients with female partners of childbearing potential) must be willing to use an adequate method of contraception for 4 weeks prior to, during and 12 weeks after the last dose of trial medication. A negative pregnancy test is required for female subjects. Adequate contraception for female subjects is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of hormonal female contraceptive. 5. Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with complete resection of primary tumor and no evidence of local relapse. 6. Metastatic disease of the liver, with recent ( 1,500/mm3 and platelets > 140,000/mm3. - Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: 1. Metastases other than liver metastases. 2. R2 and Rx resected liver metastases. 3. Chemotherapy within 4 weeks prior to randomization 4. Receipt of immunotherapy (e.g. interferons, tumor necrosis factor, interleukins, or growth factors [GM-CSF, G-CSF, M- CSF], monoclonal antibodies) within 4 weeks (28 days) prior to randomization. 5. Any known autoimmune disease, past or current. 6. A recognized immunodeficiency disease including cellular immuno-deficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies. 7. Known active hepatitis B infection and/or hepatitis C infection, known human immunodeficiency virus infection, or any other infectious process that in the opinion of the investigator could compromise the subject’s ability to mount an immune response, or expose him/ her to likelihood of more and/or severe side effects. 8. Past or current history of malignant neoplasm other than CRC, except for curatively treated non-melanoma skin cancer, in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years. 9. Medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements. 10. Clinically significant cardiac disease, e.g. cardiac failure of New York Heart Association classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, myocardial infarction in the previous 12 months as confirmed by an ECG. 11. Splenectomy. 12. Previous (less than 4 weeks prior to randomization) or concurrent treatment with a non-permitted drug. 13. Pregnancy and lactation period. 14. Participation in another clinical study within 30 days prior to randomization. 15. Known hypersensitivity to the study treatment drugs. 16. Known alcohol or drug abuse. 17. Legal incapacity or limited legal capacity. Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Recurrence-Free Survival (RFS) time and three year overall survival based on standard imaging.;Timepoint(s) of evaluation of this end point: Planned evaluation of primary endpoint: Q1 2018;Main Objective: Comparative evaluation of recurrence-free survival time and three year overall survial between the treatment groups L-BLP25 plus cyclophosphamide versus placebo vaccination and saline infusion;Secondary Objective: Comparative assessment of: - Safety / Tolerability - Recurrence free survival time in the subgroup of MUC1 positive cancers - Overall survival in the subgroup of MUC1 positive cancers | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Planned evaluation of secondary endpoint: Q1 2018;Secondary end point(s): - Safety / tolerability - Recurrence free survival of MUC1 positive cancers - Overall survival time of MUC1 positive cancers MUC1 expression analyses and Immunomonitoring parameters to be defined in a separate translational protocol. | — |
Countries
Austria, Belgium, Germany
Contacts
Public ContactSmith-Machnow
iOMEDICO AG
Outcome results
None listed