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Rituximab and Hyaluronidase Human in Treating Patients with Unresectable Stage III-IV Melanoma Undergoing Nivolumab and Ipilimumab Therapy


Active: Yes
Cancer Type: Melanoma NCT ID: NCT03719131
Trial Phases: Phase II Protocol IDs: Winship4457-18 (primary)
NCI-2018-01804
IRB00105605
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Emory University Hospital/Winship Cancer Institute
NCI Full Details: http://clinicaltrials.gov/show/NCT03719131

Summary

This phase II trial studies how well rituximab and hyaluronidase human works in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) who are undergoing nivolumab and ipilimumab therapy. Immunotherapy with rituximab and hyaluronidase human, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread.

Objectives

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 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.

EXPLORATORY OBJECTIVE:
I. To compare treatment induced changes in tumor tissue in patients receiving CCB therapy + Rituxan versus CCB therapy alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive standard of care ipilimumab intravenously (IV) over 90 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes every 4 weeks for up to 13 doses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive standard of care ipilimumab and nivolumab as in Arm A. After 1 week, patients also receive rituximab and hyaluronidase human IV or subcutaneously (SC) weekly starting week 2 for 4 doses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes every 4 weeks for up to 13 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.