Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

Study Purpose

Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients. Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients. The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient with histologically confirmed melanoma (stage I, II, III or IV based on AJCC classification) - Able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study.

Exclusion Criteria:

  • - Subject under guardianship or subject deprived of freedom.
  • - Persons benefiting from special protection (as defined in Articles L1121-5 and L1121-8 of the Public Health Code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in Articles L3212-1 and L3212-3 of the Public Health Code).
- ocular melanoma

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06154668
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Grenoble
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Julie Charles, MD, PhD
Principal Investigator Affiliation CHU Grenoble Alpes
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

: Cohort #A

monotherapy anti-PD1 first line

: Cohort #B

monotherapy anti-PD1 second line

: Cohort #C

monotherapy anti-PD1 adjuvant

: Cohort #D

combotherapy anti-PD1/CTLA-4 first line

: Cohort #E

untreated stage I and II melanoma patient

Interventions

Contact a Trial Team

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International Sites

CHU Grenoble Alpes, Grenoble, France

Status

Recruiting

Address

CHU Grenoble Alpes

Grenoble, , 38043

Site Contact

Stéphane MOURET

[email protected]

+33 (0)4 76 76 7081

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