NCT05307289Recruiting
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 10 Mar 2022
- Start date
- 25 May 2022
- Primary completion date
- 25 May 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Melanoma
- NCT number
- NCT05307289
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 25 May 2022 to the primary completion date, 25 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).
Other illness
- 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).
- A psychiatric or addiction history that will compromise the patient's ability to consent and follow the proper protocol procedures
Age
- Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed
Other
- Patients with ocular or mucosal melanoma of metastatic ocular melanoma
- 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.).
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.