Back to resultsEvaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients (IMMUSPHINX)
Primary Purpose
Melanoma
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples will be collected at different time points:
Sponsored by
About this trial
This is an interventional other trial for Melanoma focused on measuring Melanoma, Sphingolipids, Immune checkpoints, Tumor-infiltrating lymphocytes, Immunosuppressive 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 8th edition), including mucosal melanoma, without intracranial active disease.
- Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus 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 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
- Chu Nantes
- Institut Universitaire Du Cancer de Toulouse - Oncopole
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients treated with immune checkpoint inhibitor
Arm Description
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03627026
Brief Title
Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients
Acronym
IMMUSPHINX
Official Title
Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
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
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 anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care.
For each included patient, blood samples will be collected at different time points.
If feasible, an optional tumor biopsy specimen will be collected during baseline visit.
All included patients will be followed-up for tumor response and toxicity until Week 12.
After Week 12, survival data (tumor status and/or survival status) will be collected 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, Sphingolipids, Immune checkpoints, Tumor-infiltrating lymphocytes, Immunosuppressive cytokines, Circulating leukocytes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with immune checkpoint inhibitor
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood samples will be collected at different time points:
Intervention Description
Baseline
Week 6 Day 1
Week 12 Day 1
If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center.
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
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 8th edition), including mucosal melanoma, without intracranial active disease.
Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus 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 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
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
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
Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients
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