Immuno-monitoringImmunoPAXNCT02332642
Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy
An observational study of Immuno-monitoring, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immuno-monitoring
- What is being tested?
- Immuno-monitoring
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to 31 Dec 2016
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic melanoma patients (AJCC stage IV)
Who may be able to join
- histologically defined metastatic melanoma patients (AJCC stage IV)
- aged 18 to 80 years
- at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy
Who cannot join
- therapy-naive patients
- any contra-indications for (specific) systemic chemotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie
Mannheim, 68167
About this study
This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.
- Conditions
- Immuno-monitoring
- Being tested
- Immuno-monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immuno-monitoringOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno-monitoring
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immuno-monitoringStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christoffer Gebhardt, Universitätsmedizin Mannheim
- Investigators
- Christoffer Gebhardt, M.D., Principal investigator, Universitätsmedizin MannheimJochen Utikal, M.D., Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332642
- Sponsor's protocol ID
- 2014-624N-MA
- Acronym
- ImmunoPAX
- Status last verified
- Mar 2017
- First submitted
- 5 Jan 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy
- ClinicalTrials.gov ID
- NCT02332642
- Acronym / sponsor ID
- ImmunoPAX / 2014-624N-MA
- Conditions
- Immuno-monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Jan 2015 (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.
This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic melanoma patients (AJCC stage IV)
Key inclusion criteria (3 listed)
- histologically defined metastatic melanoma patients (AJCC stage IV)
- aged 18 to 80 years
- at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy
Key exclusion criteria (2 listed)
- therapy-naive patients
- any contra-indications for (specific) systemic chemotherapy
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 |
|---|---|---|
| Immuno-monitoring | Other | – |
Primary outcome
Immuno-monitoring
Time frame: Immediate
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 7 Mar 2017.
- HomepageLink provided by the sponsor.
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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.
Christoffer Gebhardt, M.D. principal investigator
Universitätsmedizin Mannheim
Jochen Utikal, M.D. principal investigator
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immuno-monitoring, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 3 inclusion and 2 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Immuno-monitoring (time frame: Immediate). It is what the study was designed to measure, not a finding.
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 7 Mar 2017.