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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A single ultra-low dose rituximab (100 mg) infusion for patients with immune-related adverse events
National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital
Herlev, Herlev, Denmark
Incidence and severity of rituximab-related adverse events graded according to CTCAE v. 6.0
Safety of rituximab is evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v. 6.0 and include the incidence and severity of rituximab-related adverse events until 6 months post treatment.
Time frame: Until 6 months post treatment
Immune-related adverse event management response
The immune-related adverse events management response, defined as number of days until symptom control (corresponding to CTCAE grade 0-1 of the immune-related adverse event)
Time frame: Until 6 months post treatment
Corticosteroid dependency
Corticosteroid dependency in rituximab treated patients measured as the number of days on corticosteroids following rituximab infusion.
Time frame: Until 6 months post treatment
Dose of corticosteroids
Assessment of rituximab efficacy measured as cumulative dose and peak dose of corticosteroids.
Time frame: Until 6 months post treatment
Second- or third-line immunosuppressants
Assessment of rituximab efficacy measured as the proportion of patients requiring second- or third-line immunosuppressive therapy after rituximab
Time frame: Until 6 months post treatment
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