V930 First in Man (FIM) Study (V930-002)(COMPLETED)

Phase 1 Completed 26 enrolled Merck Sharp & Dohme LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

Timeline

Start: 2005-09
Primary completion: 2008-09
Completion: 2008-09

Publications

Diaz CM, Chiappori A, Aurisicchio L, Bagchi A, Clark J, Dubey S, Fridman A, Fabregas JC, Marshall J, Scarselli E, La Monica N, Ciliberto G, Montero AJ. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J Transl Med. 2013 Mar 8;11:62. doi: 10.1186/1479-5876-11-62.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	V930	Vaccine	—	Intramuscular

Indications

No indication recorded.