Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
Mel-ImmAdj
1 other identifier
observational
1,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2039
September 6, 2022
September 1, 2022
10 years
May 17, 2022
September 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (3)
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)
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)
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)
Interventions
* 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
Percentages of each type of relapse (i. e. local, distant, unique or multiple) according to clinical features
Duration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and relapse date.
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.
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.
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and according to clinical features
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients under 18 years old
- Patients placed under the judicial protection
- Opposed to this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
September 6, 2022
Study Start
January 1, 2019
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2039
Last Updated
September 6, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share