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Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events

NCT07694414 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-07-22

No results posted yet for this study

Summary

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

  • Immune-Related Adverse Events

Interventions

DRUG

Rituximab (RTX)

A single ultra-low dose rituximab (100 mg) infusion for patients with immune-related adverse events

Sponsors & Collaborators

  • Inge Marie Svane

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-01
Completion
2028-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694414 on ClinicalTrials.gov