TNF in Melanoma Patients Treated With Immunotherapy (NCT03348891) | Clinical Trial Compass
CompletedNot Applicable
TNF in Melanoma Patients Treated With Immunotherapy
France60 participantsStarted 2018-09-05
Plain-language 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 ICI in the context of routine care, separated in two subgroups:
* Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
* Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
For each included patient, blood samples will be collected during baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1).
If feasible, tumor biopsy (of primary tumor or metastasis) will be performed during baseline and on Week 12 Day 1 visit (predose). If tumor biopsy is not feasible, available archived tumor specimen (frozen or FFPE block) may be collected for the study.
All included patients will be followed-up for tumor status and/or survival status every 3 months until a maximum duration of 1 year from the first study dose.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 2009), including mucosal melanoma.
✓. Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone or nivolumab + 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 to performance of any study-related procedures and to comply with the study protocol.
Exclusion criteria
What they're measuring
1
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
✕. Any condition contraindicated with sampling procedures required by the protocol.
✕. 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.
✕. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
✕. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.