Cancers Expressing HER-2 and/or CEA Clinical Trial
Official 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
| Verified date | February 2015 |
| Source | Merck Sharp & Dohme Corp. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | September 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |