MelanomaMel-ImmAdjNCT05527795
Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
An observational study of Melanoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Frequency and duration of response to adjuvant immunotherapy according to clinical features, Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features and Duration of relapse-free survival according to clinical features
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Jan 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Stage II, III and IV (resected) melanoma patients treated with surgery and adjuvant immunotherapy in the dermatology unit of Lyon-Sud hospital between January 1st of 2019 and January 1st of 2029, with no residual disease prior to immunotherapy onset.
Who may be able to join
- Patients diagnosed with stage II, III or IV (resected) melanoma
- Treated by surgery and adjuvant immunotherapy between January 1st of 2019 and January 1st of 2029
- Gave informed consent to allow the use of biological samples for research purpose
- Has read the information sheet regarding this study
- With tumor samples available at the biobank center
Who cannot join
- Patients under 18 years old
- Patients placed under the judicial protection
- Opposed to this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Stéphane Dalle, MD, PhD, +(33)478861679, stephane.dalle@chu-lyon.fr
About this study
Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.
- Conditions
- Melanoma
- Being tested
- Frequency and duration of response to adjuvant immunotherapy according to clinical features, Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features, Duration of relapse-free survival according to clinical features, Duration of overall survival according to clinical features, Overall response rate
- Keywords
- Melanoma, adjuvant immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency and duration of response to adjuvant immunotherapy according to clinical featuresOther
- Frequency of relapse to adjuvant immunotherapy according to clinical features
- Duration of relapse as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features
Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical featuresOther
Percentages of each type of relapse (i. e. local, distant, unique or multiple) according to clinical features
Duration of relapse-free survival according to clinical featuresOther
Duration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and relapse date.
Duration of overall survival according to clinical featuresOther
Duration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and the date of death (irrespectively of the cause) 10 years after inclusion in the study. Alive or lost to follow-up patients will be censored at the date of the last follow-up visit.
Overall response rateOther
Response rate to adjuvant immunotherapy and to treatment lines subsequent to relapse. Response rate to adjuvant immunotherapy is defined by the absence of relapse as assessed by the physician following the first year of adjuvant therapy. Response to treatment after relapse is defined as partial or complete response as assessed by the physician following the first year of adjuvant therapy.
Frequency of adverse events according to clinical featuresOther
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and according to clinical features
| Study group | Role | What they receive |
|---|---|---|
| Non-mutated | Non mutated (BRAF or NRAS) stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab) Receives: Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features; Other: Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features; Other: Duration of relapse-free survival according to clinical features; Other: Duration of overall survival according to clinical features; Other: Overall response rate; Other: Frequency of adverse events according to clinical features | |
| BRAF-mutated | BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab) Receives: Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features; Other: Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features; Other: Duration of relapse-free survival according to clinical features; Other: Duration of overall survival according to clinical features; Other: Overall response rate; Other: Frequency of adverse events according to clinical features | |
| NRAS-mutated | NRAS-mutated (BRAF or NRAS) stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab) Receives: Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features; Other: Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features; Other: Duration of relapse-free survival according to clinical features; Other: Duration of overall survival according to clinical features; Other: Overall response rate; Other: Frequency of adverse events according to clinical features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of response to adjuvant immunotherapy according to clinical features.
- Duration of response as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527795
- Sponsor's protocol ID
- 616
- Acronym
- Mel-ImmAdj
- Status last verified
- Sep 2022
- First submitted
- 17 May 2022
- Last updated
- 6 Sep 2022
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
- ClinicalTrials.gov ID
- NCT05527795
- Acronym / sponsor ID
- Mel-ImmAdj / 616
- Conditions
- Melanoma
- Keywords
- Melanoma, adjuvant immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2039 (estimated)
- First posted
- 6 Sep 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.
Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-mutated | – | Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features, Other: Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features, Other: Duration of relapse-free survival according to clinical features, Other: Duration of overall survival according to clinical features, Other: Overall response rate, Other: Frequency of adverse events according to clinical featuresNon mutated (BRAF or NRAS) stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab) |
| BRAF-mutated | – | Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features, Other: Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features, Other: Duration of relapse-free survival according to clinical features, Other: Duration of overall survival according to clinical features, Other: Overall response rate, Other: Frequency of adverse events according to clinical featuresBRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab) |
| NRAS-mutated | – | Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features, Other: Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features, Other: Duration of relapse-free survival according to clinical features, Other: Duration of overall survival according to clinical features, Other: Overall response rate, Other: Frequency of adverse events according to clinical featuresNRAS-mutated (BRAF or NRAS) stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stage II, III and IV (resected) melanoma patients treated with surgery and adjuvant immunotherapy in the dermatology unit of Lyon-Sud hospital between January 1st of 2019 and January 1st of 2029, with no residual disease prior to immunotherapy onset.
Key inclusion criteria (5 listed)
- Patients diagnosed with stage II, III or IV (resected) melanoma
- Treated by surgery and adjuvant immunotherapy between January 1st of 2019 and January 1st of 2029
- Gave informed consent to allow the use of biological samples for research purpose
- Has read the information sheet regarding this study
- With tumor samples available at the biobank center
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Patients placed under the judicial protection
- Opposed to this 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 |
|---|---|---|
| Frequency and duration of response to adjuvant immunotherapy according to clinical features* Frequency of relapse to adjuvant immunotherapy according to clinical features * Duration of relapse as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features | Other | BRAF-mutated, NRAS-mutated, Non-mutated |
| Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical featuresPercentages of each type of relapse (i. e. local, distant, unique or multiple) according to clinical features | Other | BRAF-mutated, NRAS-mutated, Non-mutated |
| Duration of relapse-free survival according to clinical featuresDuration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and relapse date. | Other | BRAF-mutated, NRAS-mutated, Non-mutated |
| Duration of overall survival according to clinical featuresDuration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and the date of death (irrespectively of the cause) 10 years after inclusion in the study. Alive or lost to follow-up patients will be censored at the date of the last follow-up visit. | Other | BRAF-mutated, NRAS-mutated, Non-mutated |
| Overall response rateResponse rate to adjuvant immunotherapy and to treatment lines subsequent to relapse. Response rate to adjuvant immunotherapy is defined by the absence of relapse as assessed by the physician following the first year of adjuvant therapy. Response to treatment after relapse is defined as partial or complete response as assessed by the physician following the first year of adjuvant therapy. | Other | BRAF-mutated, NRAS-mutated, Non-mutated |
| Frequency of adverse events according to clinical featuresRate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and according to clinical features | Other | BRAF-mutated, NRAS-mutated, Non-mutated |
Primary outcome
Duration of response to adjuvant immunotherapy according to clinical features.
Time frame: 1 year
• Duration of response as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- 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.
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 Melanoma, run by Hospices Civils de Lyon 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 3 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: looking for participants now, as of the sponsor's last update on 6 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Dalle, PhD (+(33)478861679, stephane.dalle@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of response to adjuvant immunotherapy according to clinical features. (time frame: 1 year). 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 6 Sep 2022.