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

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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 have non-response to the therapy in order to establish an improving response rate strategy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Nivolumab

Criteria

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