Clinical trial · Interventional
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biposy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- melanoma inclusion
- description
- 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.
- interventionNames
- Other: Biposy
Primary outcomes (1)
- measure
- Change from baseline pyrimidine metabolism at 4 years
- timeFrame
- At inclusion visit and 4 years
- description
- Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- At inclusion visit and 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available