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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06154668

Acronym

PHENOMENAL

Enrollment

707

Registered

2023-12-04

Start date

2024-01-17

Completion date

2031-01-31

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment	6 months	response to treatment according to immunological parameters at T0 between patients responding (R), stable (SD) and non-responding (NR) to treatment

Secondary

Measure	Time frame	Description
identification of early biomarkers predictive of the response to anti-PD1	at each time point (3, 4 or 6 weeks)	comparison of immunological parameters according to the type of patients (R, SD and NR) for each time point

Countries

France

Contacts

Primary ContactJulie Charles, MD, PhD

jcharles@chu-grenoble.fr476769320

Backup ContactStéphane Mouret, PhD

smouret1@chu-grenoble.fr476767081

Outcome results