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Trial Title:
Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
NCT ID:
NCT05527795
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Oxymetazoline
Immunomodulating Agents
Conditions: Keywords:
Melanoma
adjuvant immunotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Frequency and duration of response to adjuvant immunotherapy according to clinical features
Description:
- 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
Arm group label:
BRAF-mutated
Arm group label:
NRAS-mutated
Arm group label:
Non-mutated
Intervention type:
Other
Intervention name:
Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features
Description:
Percentages of each type of relapse (i. e. local, distant, unique or multiple) according
to clinical features
Arm group label:
BRAF-mutated
Arm group label:
NRAS-mutated
Arm group label:
Non-mutated
Intervention type:
Other
Intervention name:
Duration of relapse-free survival according to clinical features
Description:
Duration of relapse-free survival as defined by the time (days) between adjuvant
immunotherapy onset and relapse date.
Arm group label:
BRAF-mutated
Arm group label:
NRAS-mutated
Arm group label:
Non-mutated
Intervention type:
Other
Intervention name:
Duration of overall survival according to clinical features
Description:
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.
Arm group label:
BRAF-mutated
Arm group label:
NRAS-mutated
Arm group label:
Non-mutated
Intervention type:
Other
Intervention name:
Overall response rate
Description:
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.
Arm group label:
BRAF-mutated
Arm group label:
NRAS-mutated
Arm group label:
Non-mutated
Intervention type:
Other
Intervention name:
Frequency of adverse events according to clinical features
Description:
Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0)
and according to clinical features
Arm group label:
BRAF-mutated
Arm group label:
NRAS-mutated
Arm group label:
Non-mutated
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under 18 years old
- Patients placed under the judicial protection
- Opposed to this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Centre Hospitalier Lyon Sud
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphane Dalle, MD, PhD
Phone:
+(33)478861679
Email:
stephane.dalle@chu-lyon.fr
Start date:
January 1, 2019
Completion date:
January 1, 2039
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527795
