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

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

Completed

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Key information

Conditions

Cancers Expressing HER-2 and/or CEA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
Patients will either be disease free following primary therapy or have advanced disease with a durable response (>3 months) after standard therapy
Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

Exclusion criteria

Patients with prior treatment with any HER-2 and/or CEA containing vaccine
Patients who have significant cardiac disease
Patients with autoimmune disorders
Patients who are pregnant or lactating

Treatment and study plan

V930

Biological

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Nov 8, 2005
Registry last updated: Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.