Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-23

Study Completion Date

2017-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

NCT03225365

Metastatic Melanoma

COMPLETED NA

Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

NCT06154668

Melanoma

RECRUITING

Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors

NCT05649683

Melanoma (Skin)

RECRUITING NA

A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma

NCT02905266

Melanoma

COMPLETED PHASE3

A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US

NCT03732560

Melanoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nivolumab, patients with BRAF mutation

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

Group Type EXPERIMENTAL

blood sampling

Intervention Type BIOLOGICAL

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)

Nivolumab

Intervention Type DRUG

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.

Nivolumab, patients with BRAF wild type

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

Group Type EXPERIMENTAL

blood sampling

Intervention Type BIOLOGICAL

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)

Nivolumab

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sampling

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)

Intervention Type BIOLOGICAL

Nivolumab

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No