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

Merck Sharp & Dohme (MSD) logo

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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