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Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma (MEL-META)

Primary Purpose

Melanoma (Skin)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biposy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Melanoma (Skin)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

melanoma inclusion

Arm 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.

Outcomes

Primary Outcome Measures

Change from baseline pyrimidine metabolism at 4 years
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2022
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05307289
Brief Title
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Acronym
MEL-META
Official Title
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
May 25, 2028 (Anticipated)
Study Completion Date
October 25, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
melanoma inclusion
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Biposy
Intervention Description
Biopsy at inclusion visit and at disease progression if applicable
Primary Outcome Measure Information:
Title
Change from baseline pyrimidine metabolism at 4 years
Description
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
Time Frame
At inclusion visit and 4 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) will be measured using the Kaplan-Meier method
Time Frame
At inclusion visit and 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Montaudie Henri
Phone
+33492036488
Email
montaudie.h@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montaudie Henri
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montaudie Henri
Email
montaudie.h@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Montaudie Henri

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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