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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647114
First Posted: March 31, 2008
Last Update Posted: March 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
  Purpose
Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.

Condition Intervention Phase
Cancer Biological: V930 Biological: V932 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To determine the safety and tolerability of V930/V932 followed by EP in cancer patients [ Time Frame: Week 22 ]

Secondary Outcome Measures:
  • To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay [ Time Frame: Week 22 ]

Enrollment: 41
Study Start Date: August 2007
Study Completion Date: April 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
V930
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.
Experimental: 2
V932
Biological: 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).

Detailed Description:
The optional followup period for this study is 1 year after the last vaccination.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647114


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00647114     History of Changes
Other Study ID Numbers: V930-003
2007_671
First Submitted: March 26, 2008
First Posted: March 31, 2008
Last Update Posted: March 13, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Cancers expressing HER-2 and/or CEA