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)

NCT00647114 | Completed Phase 1

• 2 other identifiers: V930-0032007_671
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cancer

Keywords

Cancers expressing HER-2 and/or CEA

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of V930/V932 followed by EP in cancer patients

  Week 22

Secondary Outcomes (1)

• To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay

  Week 22

Study Arms (2)

1

EXPERIMENTAL

V930

Biological: V930

2

EXPERIMENTAL

V932

Biological: V932

Interventions

V930 BIOLOGICAL

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.

1

V932 BIOLOGICAL

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).

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Diaz CM, Chiappori A, Aurisicchio L, Bagchi A, Clark J, Dubey S, Fridman A, Fabregas JC, Marshall J, Scarselli E, La Monica N, Ciliberto G, Montero AJ. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J Transl Med. 2013 Mar 8;11:62. doi: 10.1186/1479-5876-11-62.

  PMID: 23497415 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 13, 2015

Record last verified: 2015-03