TNF in Melanoma Patients Treated With Immunotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
Subgroup 1
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
Intervention: Tumor biopsy specimens and blood samples (Other)
Subgroup 2
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
Intervention: Tumor biopsy specimens and blood samples (Other)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.(12 weeks per patient)