Clinical trial NCT05307289: Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Official title: Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline pyrimidine metabolism at 4 years
timeFrame: At inclusion visit and 4 years
Secondary outcomes:
measure: Overall Survival
timeFrame: At inclusion visit and 4 years
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-maritimes
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Montaudie Henri
role: PRINCIPAL_INVESTIGATOR
References: