CompletedNCT00250419Updated Feb 10, 2015

V930 First in Man (FIM) Study (V930-002)(COMPLETED)

A Phase 1 interventional study of V930 in Cancers Expressing HER-2 and/or CEA, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-10.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

Conditions studied

Cancers Expressing HER-2 and/or CEA

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
Patients will either be disease free following primary therapy or have advanced disease with a durable response (>3 months) after standard therapy
Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

Exclusion criteria

Exclusion Criteria:

Patients with prior treatment with any HER-2 and/or CEA containing vaccine
Patients who have significant cardiac disease
Patients with autoimmune disorders
Patients who are pregnant or lactating

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 26 participants (actual)

Interventions

BiologicalV930

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 23497415 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00250419
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Nov 8, 2005
Start date: Sep 2005
Primary completion: Sep 2008
Completion: Sep 2008
Last update: Feb 10, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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