NCT07694414RecruitingPhase 1
Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Inge Marie Svane
- Diseases
- Melanoma
- NCT number
- NCT07694414
- EU CT number
- 2026-525728-18-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 25
- From 15 Oct 2026 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any ongoing infectious disease
- 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
- Positive hepatitis B virus, hepatitis C virus, HIV, or tuberculosis screening
Lab values
- Low baseline IgG (\<6 g/L)
Other
- Neutropenia (\<1.5 x10\^9/L) and/or thrombocytopenia (\<75 x10\^9/L)
- Any major wounds
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.