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A Study to Test V930/V932 in Patients With Cancers Expressing Human Epidermal Growth Factor Receptor 2 (HER-2) and/or Carcinoembryonic Antigen (CEA)(V930-003)(COMPLETED)

Phase 1
Completed
Conditions
Cancer
Interventions
Biological: V930
Biological: V932
Registration Number
NCT00647114
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.

Detailed Description

The optional followup period for this study is 1 year after the last vaccination.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
Inclusion Criteria
  • Patients must have completed surgical treatment for his/her primary disease at least 1 month prior to enrollment
  • Patient must not be pregnant 3 days prior to enrollment
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Exclusion Criteria
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
  • Patient has had their spleen removed or has a history of autoimmune disorders
  • Patient is a regular user of any illicit drugs or has used within the past year of drug or alcohol abuse
  • Patient is pregnant or breastfeeding or is expecting to conceive anytime following the study
  • Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive
  • Patient has a known history of Hepatitis B or C
  • Patient has received a vaccine for any disease or condition within one month of enrollment
  • Patient has a primary central nervous system tumor.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1V930V930
2V932V932
Primary Outcome Measures
NameTimeMethod
To determine the safety and tolerability of V930/V932 followed by EP in cancer patientsWeek 22
Secondary Outcome Measures
NameTimeMethod
To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assayWeek 22
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