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Spots Global Cancer Trial Database for Immune Profiles Evolution Under Immunotherapy for Melanoma

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Trial Identification

Brief Title: Immune Profiles Evolution Under Immunotherapy for Melanoma

Official Title: Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma

Study ID: NCT04576429

Conditions

Melanoma

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dermato-oncology department, Ambroise Paré hospital, APHP, Boulogne-Billancourt, , France

Contact Details

Name: Elisa FUNCK-BRENTANO, MD

Affiliation: Dermato-oncology department, Ambroise Paré hospital, APHP

Role: PRINCIPAL_INVESTIGATOR

Name: Jean-François EMILE, MD, PhD

Affiliation: Pathology department, Ambroise Paré hospital, APHP

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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