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NCT Number: NCT06154668

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, 38043, France

Location status: Recruiting

Location contact

Julie CHARLES

PRINCIPAL_INVESTIGATOR

Stéphane MOURET

CONTACT

[email protected]

+33 (0)4 76 76 7081

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment

    Time frame: 6 months

    response to treatment according to immunological parameters at T0 between patients responding (R), stable (SD) and non-responding (NR) to treatment

Secondary outcomes

  1. identification of early biomarkers predictive of the response to anti-PD1

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Charles, MD, PhD

CONTACT

[email protected]

476769320 ext. 33

Stéphane Mouret, PhD

CONTACT

[email protected]

476767081 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Etablissement Français du Sang

Registry information

Official study title

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

Acronym: PHENOMENAL

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
Dec 4, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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