NCT03627026

Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma. The study will be conducted on a population of patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care. For each included patient, blood samples will be collected at different time points. If feasible, an optional tumor biopsy specimen will be collected during baseline visit. All included patients will be followed-up for tumor response and toxicity until Week 12. After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.

Conditions

• Melanoma

Interventions

Type	Name	Description
OTHER	Blood samples will be collected at different time points:	* Baseline * Week 6 Day 1 * Week 12 Day 1 If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center.

Timeline

• Start date: 2019-06-11
• Primary completion: 2023-09-08
• Completion: 2024-06-03
• First posted: 2018-08-13
• Last updated: 2024-06-10

Locations

2 sites across 1 country: France