TNF in Melanoma Patients Treated With Immunotherapy (MELANFα)

I

Institut Claudius Regaud

Status

Completed

Conditions

Melanoma

Treatments

Other: Tumor biopsy specimens and blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT03348891
17 CUTA 08

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Subgroup 1
Other group
Description:
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
Treatment:
Other: Tumor biopsy specimens and blood samples
Subgroup 2
Other group
Description:
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
Treatment:
Other: Tumor biopsy specimens and blood samples

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems