Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
NCT ID: NCT05527795
Last Updated: 2022-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2019-01-01
2039-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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)
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
Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features
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 features
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 features
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 rate
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 features
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and 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)
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
Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features
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 features
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 features
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 rate
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 features
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and 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)
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
Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features
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 features
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 features
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 rate
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 features
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and according to clinical features
Interventions
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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
Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features
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 features
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 features
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 rate
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 features
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and according to clinical features
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients placed under the judicial protection
* Opposed to this study
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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616
Identifier Type: -
Identifier Source: org_study_id
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