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

NCT06154668 | Recruiting

• 2 other identifiers: 38RC23.02802023-A01722-43
• Study Type: observational
• Target: 707
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• identification of early biomarkers predictive of the response to anti-PD1

  at each time point (3, 4 or 6 weeks)

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with unresectable (stage III) or metastatic (stage IV) melanoma, followed at CHU Grenoble - Alpes in Dermatology deparment for diagnosis, follow-up or recurrence of melanoma, and treated with immune checkpoint blocker in curative or adjuvant setting.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Etablissement Français du Sang: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Julie Charles, MD, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Charles, MD, PhD

CONTACT

476769320; jcharles@chu-grenoble.fr

Stéphane Mouret, PhD

CONTACT

476767081; smouret1@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: January 17, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FR (1)