The purpose of this study is to assess the safety and tolerability of CVac, an investigational cell therapy, in patients with resected stage I or II adenocarcinoma of the pancreas who have completed surgery with or without front-line chemotherapy or radiation therapy. After confirmation of non-measurable disease patients will undergo leukapheresis for manufacture of the study agent.
A total of approximately 40 patients at up to 30 clinical sites will be screened for eligibility into the study within 6 weeks of completing treatment, including R0 (complete resection with no microscopic residual tumor) or R1 (complete resection with no grossly visible tumor but microscopically positive margins) surgery for stage I or stage II adenocarcinoma of the pancreas with or without chemotherapy and radiation. Eligible patients must have no measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Eisenhauer 2009) and tumor marker carbohydrate antigen 19-9 \[CA 19-9\] not greater than 2 × the upper limit of normal (ULN) following surgery with or without chemotherapy or radiation. Prior surgery, neoadjuvant chemotherapy, adjuvant chemotherapy, and radiation therapy are allowed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cvac will be administered via intradermal injection, every 4 weeks for the first 3 doses and thereafter every 12 weeks for 3 additional doses for a total of 6
Assessment of safety and tolerability of CVac. (adverse events, vital signs, 12 lead ECG, relevant changes in physical examination)
Safety analyses will be performed on the Safety Population. Safety and tolerability will be summarized using descriptive statistics and or listed and assessed by adverse events, vital signs, 12 lead ECG, relevant changes in physical examination.
Time frame: 10-12 months
Assessment of Progression-Free Survival (PFS) and Overall Survival (OS) following the initiation of Cvac in this patient population
The efficacy endpoints for this pilot study include OS and PFS, PFS is defined as the time from baseline to the date of radiological scan used to determine Progressive disease evaluated approximately every 12 weeks after baseline.
Time frame: Participants will be followed from baseline until death from any cause or end of study, whichever comes first, assessed approximately every 12 weeks for up to 36 month
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