Immune Profiles Evolution Under Immunotherapy for Melanoma

NCT ID: NCT04576429

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2031-01-31

Brief Summary

The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.

Detailed Description

This study will analyse the association of biomarkers with relapse- or progression-free survival of stage III or IV melanoma patients, divided in 3 sub-cohorts:

• Patients treated in the adjuvant setting (cohort A): new user of immune checkpoint blockers.
• Patients treated in the metastatic setting (cohort B): - B1: new users of immune checkpoint blockers; - B2: prevalent users of immune checkpoint blockers treated with complementary radiotherapy.

For patients of cohort A and B1, immune profiles characteristics will be evaluated before initiation of treatment (=baseline), and at each radiological evaluation of the tumour response, up to maximum 12 months as duration.

The maximal duration of treatment will be 12 months for patients treated in the adjuvant setting. For metastatic patients, the duration of treatment will be decided by physician according to different factors (responses, progression, toxicities, ...).

For patients in cohort B2, the characteristics of the immune profiles will be evaluated before radiotherapy initiation,, within 6 weeks after the end of radiotherapy, then at the 2 following radiological evaluations of the tumour response

Conditions

Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Group Type: EXPERIMENTAL

venous puncture

Intervention Type: PROCEDURE

Venous punctures will be performed:

for patients of cohort A and B1:

• before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline);
• between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion);
• each 3 months up to 12 months.

for patients of cohort B2:

• before the radiotherapy;
• within the 6 weeks after the end of radiotherapy;
• at the 2 following evaluations (every 3 months).

tumoral biopsy

Intervention Type: PROCEDURE

Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.

comparator group

Group Type: ACTIVE_COMPARATOR

venous puncture

Intervention Type: PROCEDURE

Venous punctures will be performed:

for patients of cohort A and B1:

• before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline);
• between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion);
• each 3 months up to 12 months.

for patients of cohort B2:

• before the radiotherapy;
• within the 6 weeks after the end of radiotherapy;
• at the 2 following evaluations (every 3 months).

tumoral biopsy

Intervention Type: PROCEDURE

Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.

Interventions

venous puncture

Venous punctures will be performed:

for patients of cohort A and B1:

• before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline);
• between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion);
• each 3 months up to 12 months.

for patients of cohort B2:

• before the radiotherapy;
• within the 6 weeks after the end of radiotherapy;
• at the 2 following evaluations (every 3 months).

Intervention Type: PROCEDURE

tumoral biopsy

Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient aged ≥ 18 years;
• Totally resected stage III or IV melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment;
• Unresectable stage IIIC/D or IV metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ;
• Patient has been informed about the study and signed the consent;
• Affiliated to the French social security scheme.

Exclusion Criteria

• Pregnant or breastfeeding woman;
• Patient refusal;
• Patient receiving a immunosuppressor;
• Undergo a general corticotherapy of > 10 mg/kg/day since more than 7 days;
• Patient who participate to another blind interventional study receiving blinded treatment;
• Patient without any social protection by organization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisa FUNCK-BRENTANO, MD

Role: PRINCIPAL_INVESTIGATOR

Dermato-oncology department, Ambroise Paré hospital, APHP

Jean-François EMILE, MD, PhD

Role: STUDY_DIRECTOR

Pathology department, Ambroise Paré hospital, APHP

Locations

Dermato-oncology department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elisa FUNCK-BRENTANO, MD

Role: CONTACT

elisa.funck-brentano@aphp.fr

+33 (0)1 71 16 77 21

Other Identifiers

2019-A02695-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP200947

Identifier Type: -

Identifier Source: org_study_id