Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma

Recruiting

• Conditions: Melanoma
• Interventions: 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

• Registration Number: NCT05527795
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2022-05-17
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2029-01-01
• Study Completion: 2039-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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Exclusion Criteria

• Patients under 18 years old
• Patients placed under the judicial protection
• Opposed to this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRAF-mutated	Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features	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	Frequency and duration of response to adjuvant immunotherapy according to clinical features	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)
NRAS-mutated	Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features	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)
NRAS-mutated	Duration of relapse-free survival according to clinical features	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)
Non-mutated	Frequency of adverse events according to clinical features	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	Frequency and duration of response to adjuvant immunotherapy according to clinical features	BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
BRAF-mutated	Duration of relapse-free survival according to clinical features	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	Frequency of adverse events according to clinical features	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)
Non-mutated	Frequency and duration of response to adjuvant immunotherapy according to clinical features	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)
Non-mutated	Duration of relapse-free survival according to clinical features	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)
Non-mutated	Overall response rate	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	Overall response rate	BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
Non-mutated	Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features	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	Duration of overall survival according to clinical features	BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
BRAF-mutated	Frequency of adverse events according to clinical features	BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
Non-mutated	Duration of overall survival according to clinical features	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)
NRAS-mutated	Duration of overall survival according to clinical features	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)
NRAS-mutated	Overall response rate	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)

Primary Outcome Measures

Name	Time	Method
Duration of response to adjuvant immunotherapy according to clinical features.	1 year	• Duration of response as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features.

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France