NCT03627026Completed
Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients
Source: ClinicalTrials.gov · Last updated 10 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 8 Aug 2018
- Start date
- 11 Jun 2019
- Primary completion date
- 8 Sept 2023
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Melanoma
- NCT number
- NCT03627026
What you commit to
- Study type: Interventional
- Participants enrolled: 78
- From 11 Jun 2019 to the primary completion date, 8 Sept 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition contraindicated with sampling procedures required by the protocol.
- Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
Other
- Patient pregnant, or breast-feeding.
- Uveal melanoma.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Who the study is looking for
- Age ≥18 years at the time of study entry.
- Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 8th edition), including mucosal melanoma, without intracranial active disease.
- Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus ipilimumab) has been decided.
- Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
- Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started).
- ECOG Performance status 0-2.
- Life expectancy of at least 3 months.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
- Patient affiliated to a Social Health Insurance in France.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Institut Universitaire du Cancer de Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.