Back to resultsTNF in Melanoma Patients Treated With Immunotherapy (MELANFα)
Primary Purpose
Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tumor biopsy specimens and blood samples
Sponsored by
About this trial
This is an interventional other trial for Melanoma focused on measuring Melanoma, TNF, Immune checkpoints, Tumor-infiltrating lymphocytes, Cytokines, Circulating leukocytes
Eligibility Criteria
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.
- Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
- 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.
Sites / Locations
- CHRU Claude HURIEZ
- CHU Montpellier Saint-Eloi
- Institut Universitaire du Cancer de Toulouse - Oncopole
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Subgroup 1
Subgroup 2
Arm Description
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
Outcomes
Primary Outcome Measures
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Secondary Outcome Measures
Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Progression Free Survival is defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Immune related adverse event will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Full Information
NCT ID
NCT03348891
First Posted
November 16, 2017
Last Updated
November 23, 2021
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT03348891
Brief Title
TNF in Melanoma Patients Treated With Immunotherapy
Acronym
MELANFα
Official Title
TNF in Melanoma Patients Treated With Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
March 3, 2021 (Actual)
Study Completion Date
November 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, TNF, Immune checkpoints, Tumor-infiltrating lymphocytes, Cytokines, Circulating leukocytes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subgroup 1
Arm Type
Other
Arm Description
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
Arm Title
Subgroup 2
Arm Type
Other
Arm Description
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
Intervention Type
Other
Intervention Name(s)
Tumor biopsy specimens and blood samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Time Frame
12 weeks per patient
Secondary Outcome Measure Information:
Title
Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.
Time Frame
12 weeks per patient
Title
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Time Frame
12 months per patient
Title
Progression Free Survival is defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Time Frame
12 months per patient
Title
Immune related adverse event will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Time Frame
12 weeks per patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
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.
Facility Information:
Facility Name
CHRU Claude HURIEZ
City
Lille
Country
France
Facility Name
CHU Montpellier Saint-Eloi
City
Montpellier
Country
France
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
TNF in Melanoma Patients Treated With Immunotherapy
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