Examining immune responses in patients with advanced melanoma receiving treatment
Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment
NA · Hospices Civils de Lyon · NCT05029791
This study is testing how treatment affects the immune system in patients with advanced melanoma by looking at their tumor and blood samples before and after starting therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05029791 on ClinicalTrials.gov |
What this trial studies
This study investigates the changes in immune infiltrate and cell plasticity markers in patients with stage III or IV metastatic melanoma who are undergoing treatment. It involves collecting tumor biopsies and blood samples before and after the initiation of immunotherapy or targeted therapy. The study aims to enroll 100 patients and will follow them for a duration of five years to assess the impact of treatment on immune responses. The research is being conducted at the Hospices Civils de Lyon.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III or IV metastatic melanoma who are eligible for standard treatment.
Not a fit: Patients with hematologic tumors or a history of autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses in melanoma, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have shown promise in understanding immune responses in melanoma, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age ≥ 18 * Female patients must agree to the use of 2 methods of contraception. For man one method of contraception is needed if if his partner is in childbearing age throughout the study and for at least 5 months after last study treatment administration. * Patients with metastatic stage III or IV melanoma relapse * Eligible for a melanoma metastatic treatment indicated and administered as part of usual care * Patients must be willing and able to undergo cutaneous tumor biopsies (except on the face and folds or lymph node) according to the study protocol * Patient insured or beneficiary of a health insurance plan * Patient able to provide informed consent and sign approved consent forms to participate in the study * Patient accepting the conservation of biological samples and their use for clinical research including genetic research Exclusion Criteria: * Hematologic tumours under treatment * Patients with a documented history of autoimmune pathology * Ocular melanoma * Persons placed under the safeguard of justice * Use of immunosuppressants including corticosteroids 4 weeks before the inclusion
Where this trial is running
Lyon
- Service de dermatologie (Bâtiment 1A) — Lyon, France (RECRUITING)
Study contacts
- Study coordinator: Stéphane Dalle, Pr
- Email: Florence.guillemaud@chu-lyon.fr
- Phone: 04 78 86 16 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma, Immune Infiltrate, Cell plasticity markers