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NCT Number: NCT05307289

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes-maritimes, 06001, France

Location status: Recruiting

Location contact

Montaudie Henri

CONTACT

[email protected]

Montaudie Henri

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Biposy

Other

Biopsy at inclusion visit and at disease progression if applicable

Primary outcomes

  1. Change from baseline pyrimidine metabolism at 4 years

    Time frame: At inclusion visit and 4 years

    Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine

Secondary outcomes

  1. Overall Survival

    Time frame: At inclusion visit and 4 years

    Overall survival (OS) will be measured using the Kaplan-Meier method

Study contacts

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

Montaudie Henri

CONTACT

[email protected]

+33492036488

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: MEL-META

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2022
Registry last updated
Dec 31, 2025

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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