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

Civil Hospices of Lyon

Status and phase: Completed; Phase 4

Conditions: Metastatic Melanoma

Treatments: Drug: Nivolumab; Biological: blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02626065

2014.884

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Nivolumab, patients with BRAF mutation

Experimental group

Description:

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

Treatment:

Biological: blood sampling

Drug: Nivolumab

Nivolumab, patients with BRAF wild type

Experimental group

Description:

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

Treatment:

Biological: blood sampling

Drug: Nivolumab