Maintenance treatment with Cvac in patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas MedDRA version: 17.1 Level: PT Classification code 10033609 Term: Pancreatic carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Cvac
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Unknown
Other descriptive name: DC-M-FP
Concentration unit: Other
Concentration type: equal
Concentration number: 60
Sponsors
Prima BioMed Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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; 12. Oversensitivity to the substances or another component of the investigational medicinal product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of Cvac in patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas;Secondary Objective: Secondary Objectives • To assess the duration of Progression-Free Survival (PFS) and Overall Survival (OS) following the initiation of Cvac in this patient population Exploratory Objectives • To evaluate the time to next treatment (TTNT) • To evaluate immunologic response to Cvac administration in this patient population • To investigate biomarkers, including tumor and immune characteristics, of clinical efficacy of Cvac in this patient population • To assess the change in quality of life (QoL) following the initiation of Cvac in this patient population ;Primary end point(s): Safety and Tolerability;Timepoint(s) of evaluation of this end point: See Protocol Table 1 for Schedule of Safety and Tolerability Assessments Safety and tolerability will be assessed by the following: • Adverse events evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 • Clinically relevant changes from baseline in vital signs • Clinically relevant changes from screening in 12-lead ECG • Clinically relevant changes from baseline in physical examinations • Clinically relevant changes from baseline in safety laboratory assessments (haematology with differential count, biochemistry, and urinalysis) • Clinically relevant autoantibody laboratory assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EFFICACY ENDPOINTS The efficacy endpoints for this pilot study include OS and PFS. OS is defined as the number of days between the start date of treatment with Cvac and the date of death from any cause. The duration of OS will be right-censored based on the date the patient was last known to be alive for those who are alive or lost to follow-up as of the data analysis cut off date. PFS is defined as the number of days between the start date of treatment with Cvac and the earlier of documented disease progression as defined by RECIST criteria or death without prior progression. The date of disease progression or censoring for PFS will be determined according to the conventions listed in the May 2007 FDA Guidance for Industry, ‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics’ (www.fda.gov/cder/guidance/7478fnl.htm). QUALITY OF LIFE Change from baseline for the following QoL measures: • European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire (EORTC QLQ-C30, version 3) • Module QLQ-PAN26 EXPLORATORY ENDPOINTS • Time to Next Treatment (TTNT) • Change in immunologic parameters • Change in CA 19-9 • Change in ECOG performance status • Change in tumour and immune biomarkers (protein and RNA) DEFINITIONS • TTNT is defined as the time from baseline (Week 0) to the date when a next treatment for EOC is started. • PFS is defined as the time from baseline (Week 0) to the date of the radiological scan used to determine PD or date of death from any cause (PFS event). • Each patient will be assessed for PD per standard of care at the clinical site, until PD is determined by the investigator, or until death, or until end of study, whichever occurs first for the patient. • Radiological scans should be performed using the same technique (CT or MRI) throughout the study if possible. • QoL will be assessed at baseline, after each dose of study agent, and at PFS Follow-Up Visits. ;Timepoint(s) of evalua | — |
Countries
Bulgaria, Germany, Poland
Contacts
Public ContactClinical Development
Prima BioMed Ltd
Outcome results
None listed