Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

Melanoma Clinical Trial

— PHENOMENAL  

Official title:

Phenotypic, Functional, Metabolic and Transcriptomic Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154668
• Other study ID #: 38RC23.0280
• Secondary ID: 2023-A01722-43
• Status: Recruiting
• Start date: January 17, 2024
• Est. completion date: January 2031

Study information

• Verified date: February 2024
• Source: University Hospital, Grenoble
• Contact: Julie Charles, MD, PhD
• Phone: 476769320
• Email: jcharles[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients.

Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients.

The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 707
• Est. completion date: January 2031
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with histologically confirmed melanoma (stage I, II, III or IV based on AJCC classification)

• Able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study

Exclusion Criteria:

• Subject under guardianship or subject deprived of freedom

• Persons benefiting from special protection (as defined in Articles L1121-5 and L1121-8 of the Public Health Code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in Articles L3212-1 and L3212-3 of the Public Health Code).

• ocular melanoma

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Etablissement Français du Sang

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment	response to treatment according to immunological parameters at T0 between patients responding (R), stable (SD) and non-responding (NR) to treatment	6 months
Secondary	identification of early biomarkers predictive of the response to anti-PD1	comparison of immunological parameters according to the type of patients (R, SD and NR) for each time point	at each time point (3, 4 or 6 weeks)