Clinical trial · Interventional
Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune-Related Adverse Events | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab (RTX) | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab
- interventionNames
- Drug: Rituximab (RTX)
Primary outcomes (1)
- measure
- Incidence and severity of rituximab-related adverse events graded according to CTCAE v. 6.0
- timeFrame
- Until 6 months post treatment
- description
- 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.
Secondary outcomes (4)
- measure
- Immune-related adverse event management response
- timeFrame
- Until 6 months post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available