A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.

Phase 2 Completed 41 enrolled Pharmexa A/S

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.

Timeline

Start: 2006-11
Primary completion: 2008-04
Completion: 2008-04

Outcome

Missed primary endpoint

paper None of the patients had a complete or partial response to treatment PMID 20478057 ↗

Publications

Greten TF, Forner A, Korangy F, N'Kontchou G, Barget N, Ayuso C, Ormandy LA, Manns MP, Beaugrand M, Bruix J. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma. BMC Cancer. 2010 May 17;10:209. doi: 10.1186/1471-2407-10-209.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TERTOMOTIDE	Vaccine	—	—