TNF in Melanoma Patients Treated With Immunotherapy (MELANFα)

April 9, 2026 updated by: Institut Claudius Regaud

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • CHRU Claude HURIEZ
      • Montpellier, France
        • CHU Montpellier Saint-Eloi
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subgroup 1
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
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.
Other: Subgroup 2
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks per patient

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks per patient
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Time Frame: 12 months per patient
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.
Time Frame: 12 months per patient
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.
Time Frame: 12 weeks per patient
12 weeks per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2018

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

November 22, 2021

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17 CUTA 08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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