Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rituximab (RTX).
- Who it may be relevant to
- Registry conditions: Immune-Related Adverse Events. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug Rituximab (RTX)
A single ultra-low dose rituximab (100 mg) infusion for patients with immune-related adverse events
Primary outcome measures
- Incidence and severity of rituximab-related adverse events graded according to CTCAE v. 6.0 [Time frame: Until 6 months post treatment]
Secondary outcome measures (4)
- Immune-related adverse event management response [Time frame: Until 6 months post treatment]
- Corticosteroid dependency [Time frame: Until 6 months post treatment]
- Dose of corticosteroids [Time frame: Until 6 months post treatment]
- Second- or third-line immunosuppressants [Time frame: Until 6 months post treatment]
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 (<1.5 x10\^9/L) and/or thrombocytopenia (<75 x10\^9/L)
- Known hypersensitivity towards the active substance rituximab or any of the excipients
- History of cardiovascular disease including severe heart failure NYHA grade 3-4, unstable angina pectoris, atrial fibrillation, atrial flutter, and myocardial infarction
- Any major wounds
- Low baseline IgG (<6 g/L)
- Positive hepatitis B virus, hepatitis C virus, HIV, or tuberculosis screening
- Concomitant immunosuppressive medication except prednisolone
- Concomitant chemotherapy or other antineoplastic therapy (except checkpoint inhibitor therapy) within 30 days prior to inclusion
- Females of childbearing potential or males of reproductive potential who are not willing to use an effective method of contraception, such as oral, injected, or implanted hormonal methods of contraception, intrauterine device or intrauterine system, condom in combination with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream or suppository, male sterilization, or true abstinence throughout study and for a minimum of 3 months after study drug therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital — Herlev
Identifiers
NCT: NCT07694414 · AA2603 · 2026-525728-18-00