MELANFα: TNF in Melanoma Patients Treated With Immunotherapy
Study Details
Study Description
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 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:
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Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
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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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Subgroup 1 Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) |
Other: Tumor biopsy specimens and blood samples
Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.
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Other: Subgroup 2 Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab) |
Other: Tumor biopsy specimens and blood samples
Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria. [12 weeks per patient]
Secondary Outcome Measures
- Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12. [12 weeks per patient]
- Response duration is defined as the time from objective response until progression according to investigator judgment, or death. [12 months per patient]
- Progression Free Survival is defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first. [12 months per patient]
- Immune related adverse event will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. [12 weeks per patient]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years at the time of study entry.
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Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma.
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Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone or nivolumab + ipilimumab) has been decided.
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Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
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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).
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ECOG Performance status 0-2.
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Life expectancy of at least 3 months.
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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.
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Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
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Patient pregnant, or breast-feeding.
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Uveal melanoma.
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Any condition contraindicated with sampling procedures required by the protocol.
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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.
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Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
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Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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 |
Sponsors and Collaborators
- Institut Claudius Regaud
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17 CUTA 08