TNF in Melanoma Patients Treated With Immunotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18 years at the time of study entry. 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:

1. Patient pregnant, or breast-feeding. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03348891
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut Claudius Regaud
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Other: Subgroup 1

Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)

Other: Subgroup 2

Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHRU Claude HURIEZ, Lille, France

Status

Recruiting

Address

CHRU Claude HURIEZ

Lille, ,

Site Contact

Laurent MORTIER

laurent.mortier@chru-lille.fr

03 20 44 41 93

CHU Montpellier Saint-Eloi, Montpellier, France

Status

Recruiting

Address

CHU Montpellier Saint-Eloi

Montpellier, ,

Site Contact

Olivier DEREURE

o-dereure@chu-montpellier.fr

04 67 33 69 06

Toulouse, France

Status

Recruiting

Address

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , 31059

Site Contact

Nicolas MEYER

meyer.n@chu-toulouse.fr

+33 5 61 15 60 34

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