MelanomaMELANFαNCT03348891
TNF in Melanoma Patients Treated With Immunotherapy
A study testing Tumor biopsy specimens and blood samples in people with Melanoma, run by Institut Claudius Regaud at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Tumor biopsy specimens and blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 5 Sep 2018to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
CHRU Claude HURIEZ
Lille
CHU Montpellier Saint-Eloi
Montpellier
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
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:
Read more
- 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.
- Conditions
- Melanoma
- Being tested
- Tumor biopsy specimens and blood samples
- Keywords
- Melanoma, TNF, Immune checkpoints, Tumor-infiltrating lymphocytes, Cytokines, Circulating leukocytes
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Subgroup 1 | Other | Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) Receives: Other: Tumor biopsy specimens and blood samples |
| Subgroup 2 | Other | Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab) Receives: Other: Tumor biopsy specimens and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Measured: 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.
Measured: 12 weeks per patient
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Measured: 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.
Measured: 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.
Measured: 12 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start5 Sep 2018
- Primary completion3 Mar 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348891
- Sponsor's protocol ID
- 17 CUTA 08
- Acronym
- MELANFα
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2017
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40098565Dufau C, Genais M, Mucher E, Jung B, Garcia V, Montfort A, Tosolini M, Clarke CJ, Medin JA, Levade T, Delord JP, Meyer N, Pancaldi V, Andrieu-Abadie N, Segui B. Ceramide metabolism alterations contribute to Tumor Necrosis Factor-induced melanoma dedifferentiation and predict resistance to immune checkpoint inhibitors in advanced melanoma patients. Front Immunol. 2024 Jul 29;15:1421432. doi: 10.3389/fimmu.2024.1421432. eCollection 2024.
PubMed 39136013
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TNF in Melanoma Patients Treated With Immunotherapy
- ClinicalTrials.gov ID
- NCT03348891
- Acronym / sponsor ID
- MELANFα / 17 CUTA 08
- Conditions
- Melanoma
- Keywords
- Melanoma, TNF, Immune checkpoints, Tumor-infiltrating lymphocytes, Cytokines, Circulating leukocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgroup 1 | Other | Other: Tumor biopsy specimens and blood samplesPatients treated with anti-PD-1 alone (nivolumab or pembrolizumab) |
| Subgroup 2 | Other | Other: Tumor biopsy specimens and blood samplesPatients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biopsy specimens and blood samplesTumor 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 1, Subgroup 2 |
Primary outcome
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
4 secondary outcomes
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
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 40098565Virazels 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.
- Derived from this study: PubMed 39136013Dufau C, Genais M, Mucher E, Jung B, Garcia V, Montfort A, Tosolini M, Clarke CJ, Medin JA, Levade T, Delord JP, Meyer N, Pancaldi V, Andrieu-Abadie N, Segui B. Ceramide metabolism alterations contribute to Tumor Necrosis Factor-induced melanoma dedifferentiation and predict resistance to immune checkpoint inhibitors in advanced melanoma patients. Front Immunol. 2024 Jul 29;15:1421432. doi: 10.3389/fimmu.2024.1421432. eCollection 2024.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsy specimens and blood samples in people with Melanoma, run by Institut Claudius Regaud at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.