NCT02310971

Cvac as Maintenance Treatment Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

A Phase 2 Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein [Mucin 1-Glutathione S-Transferase] Coupled to Oxidized Polymannose) in Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Prima BioMed Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Carcinoma Stage I
• Pancreatic Carcinoma Stage II

Interventions

Type	Name	Description
BIOLOGICAL	CVac	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

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-12-08
• Last updated: 2015-04-03