HepaVac-101 trial with IMA970A plus CV8102 in HCC patients
Research type
Research Study
Full title
A phase I/II trial of IMA970A plus CV8102 following a single pre-vaccination infusion of cyclophosphamide in patients with very early, early and intermediate stage of hepatocellular carcinoma after any standard treatments
IRAS ID
229109
Contact name
Yuk Ting Ma
Contact email
Sponsor organisation
HepaVac Consortium @ Istituto Nazionale Tumori G. "Pascale"
Eudract number
2015-003389-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 15 days
Research summary
The main aim of the HepaVac-101 clinical study is to explore any side effects of the vaccination with IMA970A plus CV8102 following a single pre-vaccination infusion of cyclophosphamide in patients with liver cancer (hepatocellular carcinoma). Furthermore, the response of patient’s immune system to the treatment will be investigated. It is planned to treat about 40 patients in about six hospitals in about 5 European countries (Italy, Germany, United Kingdom, Spain, and Belgium. The overall start date was 19 October 2017 (in Spain) and the planned end date is August 2019. The patients will be in the screening phase 1 for up to 4 weeks, followed by a phase of standard treatment of 4 to 12 weeks (which is not study-specific), followed by a screening phase 2 of 4 weeks, a pre-treatment and treatment phase of 19 weeks, an End of Visit phase of 4-6 weeks and an observation period of up to 3 years. The total duration of the clinical trial for the individual patient will be up to 45 weeks and max. 3 years of follow-up. The sponsor of the research study is a Cancer Center named Istituto Nazionale Tumori G. „Pascale“ located in Italy. The study is funded by the European Union, the German biotech companies immatics biotechnologies GmbH and CureVac AG any by the sponsor Istituto Nazionale Tumori G. „Pascale“.” Contact point for further details is Dr. Luigi Buonaguro (info@hepavac.eu). The trial will be registered in the EU Clinical Trials Register and in clinicaltrials.gov.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0152
Date of REC Opinion
21 Mar 2018
REC opinion
Further Information Favourable Opinion