A Phase I/II Trial of TG01 and Gemcitabine Protocol V5.1
Research type
Research Study
Full title
A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas
IRAS ID
136884
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Targovax AS
Eudract number
2012-002400-40
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Pancreatic cancer is one of the major causes of cancer death globally, with a 5-year survival rate of less than 5% and there is a clear need to improve long-term survival in these patients.
TG01 is an antigen-specific cancer immunotherapy (ASCI) containing a mixture of 7 different synthetic peptides designed to encompass all common RAS mutations at positions 12 and 13.
In Europe, chemotherapy alone is now recommended as adjuvant therapy and Gemcitabine is the most frequently used adjuvant in this setting.
Combining gemcitabine with an immunotherapy approach would, in theory, offer a regimen with minimal toxicity with the aim to improve the recurrence rate and potentially offer an improved overall survival.
The study is designed in 2 parts. Part I will be initiated with 6-12 patients enrolled within 1-8 weeks after surgery to receive GM-CSF given 10-15 minutes before TG01. Gemcitabine will be started at least 3 weeks after the initiation of immunotherapy but not later than 12 weeks after surgery. Where transaminases are > 2.5 x ULN at the time of chemotherapy, 5-FU/Leucovorin may be substituted. Once 6 patients will have reach week 11, depending on DLTs seen and Immunology results obtained, the recruitment will either be extended to 12 patients or the study will move to part II or will stop. Part II will consist of adding an additional 12-18 patients treated as in part I.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
13/WM/0421
Date of REC Opinion
18 Nov 2013
REC opinion
Further Information Favourable Opinion