Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma

NCT05307289 | Recruiting

• 1 other identifier: 21-PP-20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells responsible for the anti-tumor immune response. The main objective is to evaluate metabolism modulations in melanoma cells extracted from metastases of patients sensitive and resistant to immunotherapies (anti-PD1 or anti-PD1+anti-CTLA4).

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (1)

• Change from baseline pyrimidine metabolism at 4 years

  Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine

  At inclusion visit and 4 years

Secondary Outcomes (1)

• Overall Survival

  At inclusion visit and 4 years

Study Arms (1)

melanoma inclusion

OTHER

Biopsy of a metastasis allowing melanoma diagnosis and realization of primary cultures for metabolomics. An additional 20ml blood sample will also be taken to quantify circulating metabolites and to isolate PBMC.

Other: Biposy

Interventions

Biposy OTHER

Biopsy at inclusion visit and at disease progression if applicable

melanoma inclusion

Eligibility Criteria

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

You may qualify if:

• Female or male, 18 years of age or older
• Stage III unresectable or histologically confirmed stage IV cutaneous melanoma (melanoma of unknown origin is accepted), treatment naïve (metastatic stage) and for which immunotherapy will be started
• Performance Status ≤1
• BRAF status available; BRAF status determination is required but patient will be eligible regardless of BRAF status
• For women of childbearing potential, effective contraception must be initiated during the study.
• Patient affiliated to social security plan
• Patient having signed informed consent

You may not qualify if:

• Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed
• Patients with ocular or mucosal melanoma of metastatic ocular melanoma
• Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).
• Contraindication to the initiation of immunotherapy: HIV and/or HCV and/or HBV positive, active autoimmune disease (chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease, vasculitis, etc.), patients with autoimmune motor neuropathy (such as Guillain Barré syndrome).
• Vulnerable patients: minors, adults under guardianship or curatorship, deprived of liberty
• Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
• A psychiatric or addiction history that will compromise the patient's ability to consent and follow the proper protocol procedures
• Any other clinical finding that, in the opinion of the principal investigator, could interfere with the results of the study or pose a risk to the patient during the study.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06001, 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

• Montaudie Henri

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Montaudie Henri

CONTACT

+33492036488; montaudie.h@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 1, 2022
• Study Start: May 25, 2022
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): October 25, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)