Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 25

Sponsor: Inge Marie Svane

Location: National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital Herlev Herlev

Summary

The goal of this clinical trial is to investigate the safety of rituximab for management of immune-related adverse events in malignant melanoma patients. The main questions it aims to answer are: * Is rituximab safe for management of immune-related adverse events in malignant melanoma patients? * Does rituximab provide indications of clinical benefit in the management of immune-related adverse events compared with corticosteroid treatment alone? Participants will: * Receive a single dose of 100 mg rituximab IV * Have regular follow-up consultations for 6 months following rituximab infusion * Follow a simultaneous corticosteroid tapering plan

Eligibility Criteria

Inclusion Criteria: * Histologically confirmed malignant melanoma diagnosis * Treatment with immune checkpoint inhibitors (anti-PD1, anti-PDL1, anti-LAG3 and/or anti-CTLA4) due to melanoma within 3 months * Any irAEs grade 2-4 according to CTCAE v. 6.0 * Negative pregnancy test (serum hCG) in women of childbearing potential * Age ≥ 18 years * Ability to provide written and oral consent * The patient is able to understand and read Danish Exclusion Criteria: * Any ongoing infectious disease * Neutropenia (\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07694414). StuddyBuddy aggregates publicly available trial information.