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TNF in Melanoma Patients Treated With Immunotherapy (MELANFα)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348891
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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.


Condition or disease Intervention/treatment Phase
Melanoma Other: Tumor biopsy specimens and blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: TNF in Melanoma Patients Treated With Immunotherapy
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348891


Contacts
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Contact: Nicolas MEYER +33 5 61 15 60 34 meyer.n@chu-toulouse.fr

Locations
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France
CHRU Claude HURIEZ Recruiting
Lille, France
Contact: Laurent MORTIER    03 20 44 41 93    laurent.mortier@chru-lille.fr   
CHU Montpellier Saint-Eloi Recruiting
Montpellier, France
Contact: Olivier DEREURE    04 67 33 69 06    o-dereure@chu-montpellier.fr   
Institut Universitaire du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Nicolas MEYER    +33 5 61 15 60 34    meyer.n@chu-toulouse.fr   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03348891    
Other Study ID Numbers: 17 CUTA 08
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Melanoma
TNF
Immune checkpoints
Tumor-infiltrating lymphocytes
Cytokines
Circulating leukocytes
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas