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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Rituximab (RTX)
DrugA single ultra-low dose rituximab (100 mg) infusion for patients with immune-related adverse events
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: RituximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
Dose of corticosteroids
Assessment of rituximab efficacy measured as cumulative dose and peak dose of corticosteroids.
Time frame
Until 6 months post treatment4
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 treatmentOther outcomes
1
Changes in circulating B cells
Changes in circulating B cells/B cell depletion will be evaluated by assessing changes in CD19+ and/or CD20+ B cell counts from baseline to 16 weeks post treatment.
Time frame
Until 16 weeks post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Inge Marie Svane
Lead sponsor
Herlev Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: