A Study to Test V930/V932 in Patients With Cancers Expressing Human Epidermal Growth Factor Receptor 2 (HER-2) and/or Carcinoembryonic Antigen (CEA)(V930-003)(COMPLETED)
This study has been completed.
Information provided by:
First received: March 26, 2008
Last updated: April 18, 2013
Last verified: April 2013
Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- To determine the safety and tolerability of V930/V932 followed by EP in cancer patients [ Time Frame: Week 22 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses.
V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection).
The optional followup period for this study is 1 year after the last vaccination.
Contacts and Locations