Immune Profiles Evolution Under Immunotherapy for Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (co...
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
Tracking Information
- NCT #
- NCT04576429
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elisa FUNCK-BRENTANO, MD Dermato-oncology department, Ambroise Paré hospital, APHP Study Director: Jean-François EMILE, MD, PhD Pathology department, Ambroise Paré hospital, APHP
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