NCT03348891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

November 16, 2017

Last Update Submit

April 9, 2026

Conditions

Melanoma

Keywords

MelanomaTNFImmune checkpointsTumor-infiltrating lymphocytesCytokinesCirculating leukocytes

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.

    12 weeks per patient

Secondary Outcomes (4)

  • Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.

    12 weeks per patient

  • 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

Study Arms (2)

Subgroup 1

OTHER

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

Other: Tumor biopsy specimens and blood samples

Subgroup 2

OTHER

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

Other: Tumor biopsy specimens and blood samples

Interventions

Tumor biopsy specimens and blood samplesOTHER

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.

Subgroup 1Subgroup 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU Claude HURIEZ

Lille, France

Location

CHU Montpellier Saint-Eloi

Montpellier, France

Location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location

Related Publications (1)

  • Virazels M, Lusque A, Brayer S, Genais M, Dufau C, Milhes J, Filleron T, Pages C, Sibaud V, Mortier L, Dereure O, Ayyoub M, Fabre A, Andrieu-Abadie N, Pancaldi V, Colacios C, Meyer N, Segui B, Montfort A. TNF signature in advanced melanoma patients treated with immune checkpoint inhibitors: Results from the MELANFalpha clinical study. Int J Cancer. 2025 Aug 1;157(3):534-548. doi: 10.1002/ijc.35416. Epub 2025 Mar 18.

    PMID: 40098565RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 21, 2017

Study Start

September 5, 2018

Primary Completion

March 3, 2021

Study Completion

November 22, 2021

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

FR(3)