Skip to main content
OpenTrials
Completed

NCT Number: NCT03348891

TNF in Melanoma Patients Treated With Immunotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Claude HURIEZ, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor biopsy specimens and blood samples

Other

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 outcomes

  1. 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

  1. 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

  2. Response duration is defined as the time from objective response until progression according to investigator judgment, or death.

    Time frame: 12 months per patient

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: MELANFα

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2017
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.