Clinical trial · Interventional
Immune Profiles Evolution Under Immunotherapy for Melanoma
Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
NCT04576429CI-TRIAL-00088245EPITHEMrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tumoral biopsy | Procedure | — | UNRESOLVED |
| venous puncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- interventionNames
- Procedure: venous puncture
- Procedure: tumoral biopsy
- type
- ACTIVE_COMPARATOR
- label
- comparator group
- interventionNames
- Procedure: venous puncture
- Procedure: tumoral biopsy
Primary outcomes (1)
- measure
- Rate of relapse/progression-free survival
- timeFrame
- at 5 years
- description
- Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged ≥ 18 years; * Totally resected stage III or IV melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment; * Unresectable stage IIIC/D or IV metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ; * Patient has been informed about the study and signed the consent; * Affiliated to the French social security scheme. Exclusion Criteria: * Pregnant or breastfeeding woman; * Patient refusal; * Patient receiving a immunosuppressor; * Undergo a general corticotherapy of \> 10 mg/kg/day since more than 7 days; * Patient who participate to another blind interventional study receiving blinded treatment; * Patient without any social protection by organization.
References
Publications (0)
Data not yet available
No reference posted for this study.