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Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy

Unresectable Melanoma Clinical Trial

Official title:
A Randomized Phase 2 Study of Rituxan Hycela in Patients With Advanced Melanoma Undergoing Combination Immune Checkpoint Blockade With Nivolumab and Ipilimumab

Clinical Trial Summary

This phase II trial studies whether rituximab and hyaluronidase human (Rituxan Hycela) can prevent immune related adverse events in participants with stage III-IV melanoma that cannot be removed by surgery who are undergoing nivolumab and ipilimumab therapy.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To compare rates for grade 3-4 immune-related adverse event (IRAE)s in the first 6 months in patients treated with combination checkpoint blockade (CCB) therapy (anti-CTLA4 and anti-PD1) as a part of standard of care for advanced melanoma who are treated with a single course of 4 weekly doses of rituximab and hyaluronidase human (Rituxan) therapy versus those who are not treated with Rituxan. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability (in terms of Rituxan-related adverse events) in patients with melanoma receiving CCB. II. To compare objective response rate in patients receiving CCB therapy + Rituxan versus CCB therapy alone. III. To compare 1 year overall and progression-free survival in patients receiving CCB therapy + Rituxan versus CCB therapy alone. IV. To compare changes in cluster of differentiation 21lo (CD21lo) B cells in patients receiving CCB therapy + Rituxan versus CCB therapy alone. V. To compare changes in T cells in patients receiving CCB therapy + Rituxan versus CCB therapy alone. OUTLINE: Participants are randomized to 1 of 2 arms. ARM A: Participants receive standard of care ipilimumab and nivolumab therapy. ARM B: Participants receive standard of care ipilimumab and nivolumab therapy. On day 2 of each cycle, participants also receive rituximab and hyaluronidase human intravenously (IV) or subcutaneously (SC) weekly starting week 1 for 4 doses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up for 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03719131
Study type Interventional
Source Emory University
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 5, 2019
Completion date September 13, 2024
View Details
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