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

NCT07694414 | Not Yet Recruiting Phase 1

• 2 other identifiers: AA26032026-525728-18-00
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rituximab; Immunotherapy; Checkpoint inhibitors; Malignant melanoma; Immune-related adverse event

Outcome Measures

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.

  Until 6 months post treatment

Secondary Outcomes (4)

• Immune-related adverse event management response

  Until 6 months post treatment

• Corticosteroid dependency

  Until 6 months post treatment

• Dose of corticosteroids

  Until 6 months post treatment

• Second- or third-line immunosuppressants

  Until 6 months post treatment

Other Outcomes (1)

• Changes in circulating B cells

  Until 16 weeks post treatment

Study Arms (1)

Rituximab

EXPERIMENTAL

Drug: Rituximab (RTX)

Interventions

Rituximab (RTX) DRUG

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

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Inge Marie Svane: lead

Study Sites (1)

National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Melanoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Inge Marie Svane, Professor, MD, PhD

CONTACT

004538683868; inge.marie.svane@regionh.dk

Frederikke Strauss Hansen, MD, PhD-student

CONTACT

004538683868; frederikke.strauss.hansen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)