Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
ConditionImmune-Related Adverse Events
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInge Marie Svane
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rituximab (RTX)
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Inge Marie Svane
Lead sponsor
Herlev Hospital
Sponsor institution
Source ClinicalTrials.gov