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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Cancers Expressing HER-2 and/or CEA

Treatments: Biological: V930

Study type: Interventional

Funder types: Industry

Identifiers

NCT00250419

V930-002

2005_047

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)