Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-09-05
2021-11-22
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Subgroup 1
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
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.
Subgroup 2
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma.
3. Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone or nivolumab + ipilimumab) has been decided.
4. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
5. 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).
6. ECOG Performance status 0-2.
7. Life expectancy of at least 3 months.
8. 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.
9. Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria
2. Uveal melanoma.
3. Any condition contraindicated with sampling procedures required by the protocol.
4. 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.
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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CHRU Claude HURIEZ
Lille, , France
CHU Montpellier Saint-Eloi
Montpellier, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Countries
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Other Identifiers
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17 CUTA 08
Identifier Type: -
Identifier Source: org_study_id