Immune Profiles Evolution Under Immunotherapy for Melanoma (EPITHEM)
Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elisa FUNCK-BRENTANO, MD
- Phone Number: +33 (0)1 71 16 77 21
- Email: elisa.funck-brentano@aphp.fr
Study Locations
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Boulogne-Billancourt, France, 92100
- Recruiting
- Dermato-oncology Department, Ambroise Paré Hospital, APHP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
Venous punctures will be performed: for patients of cohort A and B1:
for patients of cohort B2:
Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.
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Active Comparator: comparator group
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Venous punctures will be performed: for patients of cohort A and B1:
for patients of cohort B2:
Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of relapse/progression-free survival
Time Frame: at 5 years
|
Will be noted: all progression and event of death.
Survival rate will be calculated between the event's day and the beginning of anticancer treatment.
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at 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
immunity profiles
Time Frame: quarterly up to 12 months
|
ELISA Multiplex method will be used to analyse inflammatory human cytokines in plasma. This method will performe an assay 45-plex fixed panel : Analytes Included in the Assay
|
quarterly up to 12 months
|
Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP200947
- 2019-A02695-52 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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