Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06154668
Collaborator
Etablissement Français du Sang (Other)
707
Enrollment
96
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    707 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Phenotypic, Functional, Metabolic and Transcriptomic Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2030
    Anticipated Study Completion Date :
    Dec 1, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort #A

    monotherapy anti-PD1 first line
    Cohort #B

    monotherapy anti-PD1 second line
    Cohort #C

    monotherapy anti-PD1 adjuvant
    Cohort #D

    combotherapy anti-PD1/CTLA-4 first line
    Cohort #E

    untreated stage I and II melanoma patient

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Grenoble
    • Etablissement Français du Sang

    Investigators

    • Principal Investigator: Julie Charles, MD, PhD, CHU Grenoble Alpes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT06154668
    Other Study ID Numbers:
    • 38RC23.0280
    • 2023-A01722-43
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Dec 4, 2023