Malignant MelanomaPhase 2NCT00651703
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
A Phase 2 study testing CYT004-MelQbG10 + Montanide, CYT004-MelQbG10 + Montanide + Imiquimod and CYT004-MelQbG10 + Imiquimod in people with Malignant Melanoma, run by Cytos Biotechnology AG at 2 sites in Switzerland.
Trial summary
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- CYT004-MelQbG10 + Montanide, CYT004-MelQbG10 + Montanide + Imiquimod and CYT004-MelQbG10 + Imiquimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2008to Jul 2010
- Phase
- Phase 2
- 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
- Histological confirmed Stage III or IV malignant melanoma
- HLA-A*0201 haplotype
- Expected survival of at least 9 months
- Willing and able to comply with all trial requirements (e.g. diaries, CTs)
- Given written informed consent
- Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception
Who cannot join
- Any contraindication to any study related test or assessment
- Current or planned use of contraindicated concomitant medication
- Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
- Infection with HIV, HBV or HCV
- Pregnancy or lactation or females planning to become pregnant during the study
- Abuse of alcohol or other drugs
- Use of investigational drug within 30 days before enrolment
- Previous participation in a clinical trial with a Qb-based Cytos vaccine.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Ludwig Institute for Cancer Research; CHUV
Lausanne, Canton of Vaud, CH-1005
Dermatologische Klinik, UniversitätsSpital Zürich
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.
- Conditions
- Malignant Melanoma
- Being tested
- CYT004-MelQbG10 + Montanide, CYT004-MelQbG10 + Montanide + Imiquimod, CYT004-MelQbG10 + Imiquimod, CYT004-MelQbG10 intra nodal injection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT004-MelQbG10 + MontanideBiological
CYT004-MelQbG10 + Montanide + ImiquimodBiological
CYT004-MelQbG10 + ImiquimodBiological
CYT004-MelQbG10 intra nodal injectionBiological
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CYT004-MelQbG10 + Montanide |
| 2 | Experimental | Not described Receives: Biological: CYT004-MelQbG10 + Montanide + Imiquimod |
| 3 | Experimental | Not described Receives: Biological: CYT004-MelQbG10 + Imiquimod |
| 4 | Experimental | Not described Receives: Biological: CYT004-MelQbG10 intra nodal injection |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651703
- Sponsor's protocol ID
- CYT004-MelQbG10 04
- Status last verified
- Nov 2010
- First submitted
- 1 Apr 2008
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00651703
- Acronym / sponsor ID
- CYT004-MelQbG10 04
- Conditions
- Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Apr 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.
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CYT004-MelQbG10 + Montanide |
| 2 | Experimental | Biological: CYT004-MelQbG10 + Montanide + Imiquimod |
| 3 | Experimental | Biological: CYT004-MelQbG10 + Imiquimod |
| 4 | Experimental | Biological: CYT004-MelQbG10 intra nodal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological confirmed Stage III or IV malignant melanoma
- HLA-A*0201 haplotype
- Expected survival of at least 9 months
- Willing and able to comply with all trial requirements (e.g. diaries, CTs)
- Given written informed consent
Key exclusion criteria (8 listed)
- Any contraindication to any study related test or assessment
- Current or planned use of contraindicated concomitant medication
- Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
- Infection with HIV, HBV or HCV
- Pregnancy or lactation or females planning to become pregnant during the study
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 |
|---|---|---|
| CYT004-MelQbG10 + Montanide | Biological | 1 |
| CYT004-MelQbG10 + Montanide + Imiquimod | Biological | 2 |
| CYT004-MelQbG10 + Imiquimod | Biological | 3 |
| CYT004-MelQbG10 intra nodal injection | Biological | 4 |
Primary outcome
Not reported in the source record.
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 15 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT004-MelQbG10 + Montanide, CYT004-MelQbG10 + Montanide + Imiquimod and CYT004-MelQbG10 + Imiquimod in people with Malignant Melanoma, run by Cytos Biotechnology AG at 2 sites in Switzerland.
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 6 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 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 15 Nov 2010.