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: V930Biological: 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
Group Intervention Description 1 V930 V930 2 V932 V932
- Primary Outcome Measures
Name Time Method To determine the safety and tolerability of V930/V932 followed by EP in cancer patients Week 22
- Secondary Outcome Measures
Name Time Method To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay Week 22