Metastatic MelanomaPhase 4PAIRNCT02626065
Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
A Phase 4 study testing blood sampling and Nivolumab in people with Metastatic Melanoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- blood sampling and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2015to 28 Dec 2017
- Phase
- Phase 4
- 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
- Men and women aged ≥ 18 years
- Patient with metastatic or unresectable melanoma
- Anti-PD1 monoclonal antibodies treatment indication
- Patient affiliated to a social security regime
- Signed Written Informed Consent.
- agree with the storage of his biological samples
- Women of childbearing potential must as mentioned in the summary of product characteristics (SPC) using two effective methods of contraception during treatment, and men whose partner is of childbearing potential must use effective contraception during treatment. For all patients treated men and women, contraception should be continued during the four months following the discontinuation of nivolumab.
Who cannot join
- development of haematological tumor during treatment
- Patients requiring concomitant chronic treatment with systemic corticosteroids or other immunosuppressive agents
- Patients with autoimmune disease.
- Patient with Occular melanoma
Trial locations and contacts
1 site in 1 country.
About this study
This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.
- Conditions
- Metastatic Melanoma
- Being tested
- blood sampling, Nivolumab
- Keywords
- Melanoma, Anti-PD1 monoclonal antibodies, Immune modulation, BRAF
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
Blood samples (44mL) will be taken before starting treatment with Nivolumab and at week 2, week 12, week 54 or at relapse (before week 54)
NivolumabDrug
injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab, patients with BRAF mutation | Experimental | Nivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks.
Blood sampling at different time Receives: Biological: blood sampling; Drug: Nivolumab |
| Nivolumab, patients with BRAF wild type | Experimental | Nivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks.
Blood sampling at different time Receives: Biological: blood sampling; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change the absolute number of dendritic cells before treatment and on treatment
absolute number / mm 3 of dendritic cells
Measured: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment
% of cells producing cytokines in dendritic cells
Measured: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the absolute number of subpopulations of T lymphocytes before treatment and on treatment
absolute number / mm 3 of different subpopulations of T lymphocyte
Measured: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the absolute number of monocytes before treatment and on treatment
absolute number / mm 3 of monocytes
Measured: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment
% of cells producing cytokines in subpopulations of T lymphocytes
Measured: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
change the percentage of cells producing cytokines in monocytes before treatment and on treatment
% of cells producing cytokines in monocytes
Measured: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
Secondary outcomes (5)
correlation between biological parameters and progression-free survival
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with the progression free survival
Measured: progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion
correlation between biological parameters on overall survival
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with the overall survival
Measured: death between the date of first injection of immunotherapy and week 54
Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria
predictive factors like histological and cytological initial tumor type, initial immunological status will be evaluated at inclusion and correlated with the response
Measured: response evaluation at week 12
impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with treatments received prior to inclusion
Measured: antitumor treatment received from diagnosis of melanoma to inclusion
correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment
absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with autoimmune side effects, based on CTCAE classification
Measured: occurence of autoimmune side effects from day 0 to week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start23 Apr 2015
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626065
- Sponsor's protocol ID
- 2014.884
- Acronym
- PAIR
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2015
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalle S, Verronese E, N'Kodia A, Bardin C, Rodriguez C, Andrieu T, Eberhardt A, Chemin G, Hasan U, Le-Bouar M, Caramel J, Amini-Adle M, Bendriss-Vermare N, Dubois B, Caux C, Menetrier-Caux C. Modulation of blood T cell polyfunctionality and HVEM/BTLA expression are critical determinants of clinical outcome in anti-PD1-treated metastatic melanoma patients. Oncoimmunology. 2024 Jun 26;13(1):2372118. doi: 10.1080/2162402X.2024.2372118. eCollection 2024.
PubMed 38939518
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies
- ClinicalTrials.gov ID
- NCT02626065
- Acronym / sponsor ID
- PAIR / 2014.884
- Conditions
- Metastatic Melanoma
- Keywords
- Melanoma, Anti-PD1 monoclonal antibodies, Immune modulation, BRAF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- 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 is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab, patients with BRAF mutation | Experimental | Biological: blood sampling, Drug: NivolumabNivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. Blood sampling at different time |
| Nivolumab, patients with BRAF wild type | Experimental | Biological: blood sampling, Drug: NivolumabNivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. Blood sampling at different time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged ≥ 18 years
- Patient with metastatic or unresectable melanoma
- Anti-PD1 monoclonal antibodies treatment indication
- Patient affiliated to a social security regime
- Signed Written Informed Consent.
Key exclusion criteria (4 listed)
- development of haematological tumor during treatment
- Patients requiring concomitant chronic treatment with systemic corticosteroids or other immunosuppressive agents
- Patients with autoimmune disease.
- Patient with Occular melanoma
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 |
|---|---|---|
| blood samplingBlood samples (44mL) will be taken before starting treatment with Nivolumab and at week 2, week 12, week 54 or at relapse (before week 54) | Biological | Nivolumab, patients with BRAF mutation, Nivolumab, patients with BRAF wild type |
| Nivolumabinjection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. | Drug | Nivolumab, patients with BRAF mutation, Nivolumab, patients with BRAF wild type |
Primary outcome
change the absolute number of dendritic cells before treatment and on treatment
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
absolute number / mm 3 of dendritic cells
change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
% of cells producing cytokines in dendritic cells
change the absolute number of subpopulations of T lymphocytes before treatment and on treatment
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
absolute number / mm 3 of different subpopulations of T lymphocyte
change the absolute number of monocytes before treatment and on treatment
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
absolute number / mm 3 of monocytes
change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
% of cells producing cytokines in subpopulations of T lymphocytes
change the percentage of cells producing cytokines in monocytes before treatment and on treatment
Time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)
% of cells producing cytokines in monocytes
5 secondary outcomes
correlation between biological parameters and progression-free survival
Time frame: progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion
correlation between biological parameters on overall survival
Time frame: death between the date of first injection of immunotherapy and week 54
Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria
Time frame: response evaluation at week 12
impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment
Time frame: antitumor treatment received from diagnosis of melanoma to inclusion
correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment
Time frame: occurence of autoimmune side effects from day 0 to week 54
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 15 Sep 2025.
- Results publication: PubMed 38939518Dalle S, Verronese E, N'Kodia A, Bardin C, Rodriguez C, Andrieu T, Eberhardt A, Chemin G, Hasan U, Le-Bouar M, Caramel J, Amini-Adle M, Bendriss-Vermare N, Dubois B, Caux C, Menetrier-Caux C. Modulation of blood T cell polyfunctionality and HVEM/BTLA expression are critical determinants of clinical outcome in anti-PD1-treated metastatic melanoma patients. Oncoimmunology. 2024 Jun 26;13(1):2372118. doi: 10.1080/2162402X.2024.2372118. eCollection 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing blood sampling and Nivolumab in people with Metastatic Melanoma, run by Hospices Civils de Lyon at 1 site 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 7 inclusion and 4 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change the absolute number of dendritic cells before treatment and on treatment (time frame: before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks)). The study lists 6 primary outcomes in all. 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 NCT02626065, which also lists 1 linked publication.
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 15 Sep 2025.