Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma (Mel-ImmAdj)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Melanoma

Treatments: Other: Frequency of adverse events according to clinical features; Other: Duration of relapse-free survival according to clinical features; Other: Duration of overall survival 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: Overall response rate; Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features

Study type: Observational

Funder types: Other

Identifiers

NCT05527795

616

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 3 patient groups

Non-mutated

Description:

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)

Treatment:

Other: Overall response rate

Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features

Other: Duration of relapse-free survival 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: Frequency of adverse events according to clinical features

Other: Duration of overall survival according to clinical features

BRAF-mutated

Description:

BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)

Treatment:

Other: Overall response rate

Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features

Other: Duration of relapse-free survival 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: Frequency of adverse events according to clinical features

Other: Duration of overall survival according to clinical features

NRAS-mutated

Description:

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)

Treatment:

Other: Overall response rate

Other: Frequency and duration of response to adjuvant immunotherapy according to clinical features

Other: Duration of relapse-free survival 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: Frequency of adverse events according to clinical features

Other: Duration of overall survival according to clinical features