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)

Cancer Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647114
• Other study ID #: V930-003
• Secondary ID: 2007_671
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2008
• Last updated: March 12, 2015
• Start date: August 2007
• Est. completion date: April 2009

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• V930
V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses.
• V932
V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of V930/V932 followed by EP in cancer patients		Week 22	Yes
Secondary	To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay		Week 22	No