Immune Profiles Evolution Under Immunotherapy for Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04576429
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elisa FUNCK-BRENTANO, MDJean-François EMILE, MD, PhD
Principal Investigator Affiliation	Dermato-oncology department, Ambroise Paré hospital, APHPPathology department, Ambroise Paré hospital, APHP
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Additional Details

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

Arms & Interventions

Arms

Experimental: experimental group

Active Comparator: comparator group

Interventions

Procedure: - 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).

Procedure: - tumoral biopsy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Boulogne-Billancourt, France

Status

Recruiting

Address

Dermato-oncology department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, , 92100

Site Contact

[email protected]

+33 (0)1 71 16 77 21

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