Status:
COMPLETED
TNF in Melanoma Patients Treated With Immunotherapy
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 im...
Eligibility Criteria
Inclusion
- 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.
- Patient affiliated to a Social Health Insurance in France.
Exclusion
- Patient pregnant, or breast-feeding.
- Uveal melanoma.
- 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.
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03348891
Start Date
September 5 2018
End Date
November 22 2021
Last Update
November 24 2021
Active Locations (3)
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1
CHRU Claude HURIEZ
Lille, France
2
CHU Montpellier Saint-Eloi
Montpellier, France
3
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31059