V930 First in Man (FIM) Study (V930-002)(COMPLETED)
Phase 1
Completed
- Conditions
- Cancers Expressing HER-2 and/or CEA
- Registration Number
- NCT00250419
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method