Metastatic MelanomaNCT05510466
Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis
An observational study of Metastatic Melanoma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Metastatic melanoma BRAF mutated * Initially treated by a doubled targeted therapy anti BRAF/anti MEK * With an intra cerebral progression of the tumor * Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy * between 01/2019 et 01/2022
Who may be able to join
- Metastatic melanoma BRAF mutated
- Initially treated by a doubled targeted therapy anti BRAF/anti MEK
- With an intra cerebral progression of the tumor
- Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy
- between 01/2019 et 01/2022
Who cannot join
- Other condition
Trial locations and contacts
1 site in 1 country.
Marie Louise Jeanne, resident contact
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Olivier DEREURE, MD, PhD, 467336906 ext. 33, o-dereure@chu-montpellier.fr
About this study
Official title: Analysis of Efficiency and Tolerance of Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis Occuring During First-line BRAFinh/MEKinh Therapy.
Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.
- Conditions
- Metastatic Melanoma
- Keywords
- Initially treated by a doubled targeted therapy anti BRAF/anti MEK, immunotherapy, combined tritherapy, melanoma's brain metastasis, With an intra cerebral progression of the tumor
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between intra and extra cerebral metastasis
comparison between intra and extra cerebral metastasis
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jan 2019
- Primary completion20 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Louise Jeanne, resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510466
- Sponsor's protocol ID
- RECHMPL22_0016
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Efficiency and Tolerance of Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis Occuring During First-line BRAFinh/MEKinh Therapy.
- ClinicalTrials.gov ID
- NCT05510466
- Acronym / sponsor ID
- RECHMPL22_0016
- Conditions
- Metastatic Melanoma
- Keywords
- Initially treated by a doubled targeted therapy anti BRAF/anti MEK, immunotherapy, combined tritherapy, melanoma's brain metastasis, With an intra cerebral progression of the tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- 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.
Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Metastatic melanoma BRAF mutated * Initially treated by a doubled targeted therapy anti BRAF/anti MEK * With an intra cerebral progression of the tumor * Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy * between 01/2019 et 01/2022
Key inclusion criteria (5 listed)
- Metastatic melanoma BRAF mutated
- Initially treated by a doubled targeted therapy anti BRAF/anti MEK
- With an intra cerebral progression of the tumor
- Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy
- between 01/2019 et 01/2022
Key exclusion criteria (1 listed)
- Other condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison between intra and extra cerebral metastasis
Time frame: day 1
comparison between intra and extra cerebral metastasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Marie Louise Jeanne, resident contact
Marie Louise Jeanne, resident principal investigator
University Hospital, Montpellier
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 Metastatic Melanoma, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier DEREURE, MD, PhD (467336906 ext. 33, o-dereure@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between intra and extra cerebral metastasis (time frame: day 1). 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 22 Aug 2022.