Immune Profiles Evolution Under Immunotherapy for Melanoma

Melanoma Clinical Trial

— EPITHEM  

Official title:

Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04576429
• Other study ID #: APHP200947
• Secondary ID: 2019-A02695-52
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: January 2031

Study information

• Verified date: February 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Elisa FUNCK-BRENTANO, MD
• Phone: +33 (0)1 71 16 77 21
• Email: elisa.funck-brentano[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: January 2031
• Est. primary completion date: January 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
France	Dermato-oncology department, Ambroise Paré hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of relapse/progression-free survival	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.	at 5 years
Secondary	immunity profiles	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; CCL2/JE/MCP-1; CCL3/MIP-1 alpha; CCL4/MIP-1 beta; CCL5/RANTES; CCL11/Eotaxin; CCL19/MIP-3 beta; CCL20/MIP-3 alpha; CD40 Ligand/TNFSF5; CX3CL1/Fractalkine; CXCL1/GRO alpha/KC/CINC-1; CXCL2/GRO beta/MIP-2/CINC-3; CXCL10/IP-10/CRG-2; EGF; FGF basic/FGF2/bFGF; Flt-3 Ligand/FLT3L; G-CSF; GM-CSF; Granzyme B; IFN-alpha 2/IFNA2; IFN-beta; IFN-gamma; IL-1 alpha/IL-1F1; IL-1 beta/IL-1F2; IL-1ra/IL-1F3; IL-2; IL-3; IL-4; IL-5; IL-6; IL-7; IL-8/CXCL8; IL-10; IL-12 p70; IL-13; IL-15; IL-17/IL-17A; IL-17E/IL-25; IL-33; PD-L1/B7-H1; PDGF-AA; PDGF-AB/BB; TGF-alpha; TNF-alpha; TRAIL/TNFSF10; VEGF	quarterly up to 12 months