CancerPhase 1NCT00647114
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)
A Phase 1 study testing V930 and V932 in people with Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- V930 and V932
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.
Read the detailed description
The optional followup period for this study is 1 year after the last vaccination.
- Conditions
- Cancer
- Being tested
- V930, V932
- Keywords
- Cancers expressing HER-2 and/or CEA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V930Biological
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.
V932Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | V930 Receives: Biological: V930 |
| 2 | Experimental | V932 Receives: Biological: V932 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of V930/V932 followed by EP in cancer patients
Measured: 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
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647114
- Sponsor's protocol ID
- V930-003
- Other IDs
- 2007_671
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2008
- Last updated
- 13 Mar 2015
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00647114
- Acronym / sponsor ID
- V930-003
- Conditions
- Cancer
- Keywords
- Cancers expressing HER-2 and/or CEA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: V930V930 |
| 2 | Experimental | Biological: V932V932 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V930V930 - 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. | Biological | 1 |
| V932V932 - 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). | Biological | 2 |
Primary outcome
To determine the safety and tolerability of V930/V932 followed by EP in cancer patients
Time frame: Week 22
1 secondary outcome
To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay
Time frame: Week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Derived from this study: PubMed 23497415Diaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V930 and V932 in people with Cancer, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and tolerability of V930/V932 followed by EP in cancer patients (time frame: Week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.