Metastatic MelanomaLENVAMELNCT06586580
Treatment of Metastatic Melanoma with Lenvatinib + Anti-PD1
An observational study of Metastatic Melanoma, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The hypothesis is that treatment with Lenvatinib + Pembrolizumab is less effective in real life than in clinical trials. In fact, an objective response rate \< 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected. 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
- 30 Mar 2023to 31 Dec 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 (stage III non operable or stage IV according to AJCC)
Who may be able to join
- Metastatic melanoma (stage III non operable or stage IV according to American Joint Committee on Cancer staging rules) refractory to immunotherapy (≥ 2nd treatment line after minimum a failure of immunotherapy)
Who cannot join
- Uveal melanoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Le Traitement Par Lenvatinib + Anti-PD1 Du Mélanome Métastatique
The hypothesis is that treatment with Lenvatinib + Pembrolizumab is less effective in real life than in clinical trials. In fact, an objective response rate \< 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected.
- Conditions
- Metastatic Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic melanoma | Metastatic melanoma refractory to immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: Month 18
Secondary outcomes (3)
Progression-free survival
Measured: Month 18
Overall survival
Measured: Month 18
Frequencies of severe toxicities leading to treatment interruption
According to Common Terminology Criteria for Adverse Events [CTACE] V5, grade III and IV
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Centre Hospitalier Universitaire de BesanconThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586580
- Sponsor's protocol ID
- 2023/757
- Acronym
- LENVAMEL
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Le Traitement Par Lenvatinib + Anti-PD1 Du Mélanome Métastatique
- ClinicalTrials.gov ID
- NCT06586580
- Acronym / sponsor ID
- LENVAMEL / 2023/757
- Conditions
- Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Sep 2024 (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.
The hypothesis is that treatment with Lenvatinib + Pembrolizumab is less effective in real life than in clinical trials. In fact, an objective response rate \< 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic melanoma | – | –Metastatic melanoma refractory to immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic melanoma (stage III non operable or stage IV according to AJCC)
Key inclusion criteria (1 listed)
- Metastatic melanoma (stage III non operable or stage IV according to American Joint Committee on Cancer staging rules) refractory to immunotherapy (≥ 2nd treatment line after minimum a failure of immunotherapy)
Key exclusion criteria (1 listed)
- Uveal melanoma
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
Objective response rate
Time frame: Month 18
3 secondary outcomes
Progression-free survival
Time frame: Month 18
Overall survival
Time frame: Month 18
Frequencies of severe toxicities leading to treatment interruption
Time frame: Month 18
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
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 Centre Hospitalier Universitaire de Besancon 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 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
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?
Objective response rate (time frame: Month 18). 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 19 Sep 2024.