Clinical trial of Cvac in patients with pancreatic cancer

Conditions: Maintenance treatment with Cvac in patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas
MedDRA version: 17.1Level: PTClassification code 10033609Term: Pancreatic carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-000676-26-BG

Lead Sponsor: Prima BioMed Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients may be enrolled if they meet all of the following criteria at screening:
1. Histologically or cytologically diagnosed adenocarcinoma of the pancreas, stage I or stage II disease;
2. Postoperative confirmed R0 or R1 resection status with no evidence of residual disease based on radiographic imaging;
3. CA 19-9 less than 2 × the ULN by the central laboratory;
4. No greater than 6 weeks since completion of prior therapy, which includes surgery with or without radiation or chemotherapy;
5. Mucin 1-positive tumor as determined by central immunohistopathology. Sites will be asked to submit archival tissue (patients may start the study if tissue is available at an outside hospital, but not yet requested or received);
6. Signed an ICF;
7. Willing and able to complete study procedures within the study timelines;
8. Life expectancy of at least 6 months in the investigator’s opinion;
9. = 18 years of age;
10. ECOG performance status < 2 (Karnofsky = 70%);
11. Normal organ and marrow function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × ULN and serum bilirubin = 1.5 × ULN unless Gilbert’s syndrome has previously been confirmed for the patient, white blood cells (WBCs) = 3.0 K/µL, absolute neutrophil count (ANC) = 1.0 × 109/L, hemoglobin = 8 g/dL, and platelets = 100 × 109/L;
12. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of Cvac. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above.
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Active, acute, or chronic clinically significant infections or bleeding;
2. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) or history of congestive heart failure (= Grade 2);
3. Active angina pectoris, stroke, or recent myocardial infarction (within 6 months);
4. Additional uncontrolled, serious medical or psychiatric illness;
5. Evidence or history of central nervous system metastases;
6. Inadequate renal function defined as a creatinine clearance < 60 mL/min as determined by the central laboratory;
7. Additional malignancy diagnosed within 5 years of study enrolment, except carcinoma in situ of the cervix or basal cell and squamous cell carcinomas of the skin;
8. Treatment with any other investigational agent (for any condition) within 4 weeks of screening;
9. Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum [TPHA]);
10. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose;
11. Active autoimmune disease; any previous autoimmune disease must not require chronic treatment in the 6 months prior to screening.