Study on Rituximab and Hyaluronidase Human for Patients with Advanced Melanoma Receiving Nivolumab and Ipilimumab Therapy

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT03719131

Provider View

This clinical trial is exploring whether adding Rituximab and Hyaluronidase Human to standard treatments can help prevent immune-related side effects in patients with advanced melanoma undergoing therapy with nivolumab and ipilimumab.

Patient Parameters

Program Overview

The purpose of this study is to see if using Rituximab and Hyaluronidase Human (Rituxan Hycela) can help prevent serious immune-related side effects in patients with advanced melanoma who are receiving standard treatments with nivolumab and ipilimumab. The study will compare patients who receive Rituxan Hycela with those who do not, to see if there is a difference in side effects and treatment outcomes.

Description

The main goal of this study is to compare the occurrence of serious immune-related side effects in patients with advanced melanoma who are treated with standard combination therapy (nivolumab and ipilimumab) and those who also receive Rituximab and Hyaluronidase Human (Rituxan Hycela).

Secondary goals include:

  • Evaluating the safety and side effects of Rituxan Hycela in these patients.
  • Comparing how well the cancer responds to treatment with and without Rituxan Hycela.
  • Comparing survival rates and how long patients live without the cancer getting worse.
  • Examining changes in specific immune cells in patients receiving Rituxan Hycela compared to those who do not.

Participants will be randomly assigned to one of two groups:

  • Group A: Receives standard treatment with nivolumab and ipilimumab.
  • Group B: Receives standard treatment with nivolumab and ipilimumab, plus Rituxan Hycela once a week for four weeks.

After completing the study treatment, participants will be monitored for four weeks.

Eligibility Criteria

Inclusion Criteria

  • Eligible to receive standard combination therapy with nivolumab and ipilimumab for advanced melanoma that cannot be removed by surgery.
  • No treatment with immune checkpoint inhibitors in the past year, except for certain cases where single-agent therapy was given over a year ago without severe side effects.
  • Recent blood tests showing:
    • White blood cell count of at least 3,000/µL
    • Neutrophil count of at least 1,500/µL
    • Platelet count of at least 100,000/µL
    • Hemoglobin level of at least 9 g/dL
    • Normal kidney and liver function within specified limits
  • Total bilirubin within normal limits, except for certain conditions like Gilbert's syndrome
  • Serum lactate dehydrogenase (LDH) within specified limits

Exclusion Criteria

  • Allergy to Rituximab or its ingredients.
  • Active or untreated cancer spread to the brain or spinal cord, unless treated and stable.
  • Previous treatment with certain immune therapies, unless given over a year ago without severe side effects.
  • Women who are pregnant or breastfeeding.
  • Positive for HIV, active Hepatitis B or C, or history of these infections.
  • Active autoimmune disorders, except for certain conditions like vitiligo or thyroiditis.
  • Active inflammatory bowel disease.
  • Use of corticosteroids, except for certain conditions like adrenal insufficiency.
  • Serious medical conditions or medications that may interfere with the study.

Locations

FACILITYZIPCITYSTATE
Emory University Hospital/Winship Cancer Institute30322AtlantaGeorgia

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