Rituximab for treating immune-related side effects from checkpoint inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study aims to assess the safety of a single 100 mg intravenous dose of rituximab in patients who develop immune-related adverse events while receiving checkpoint inhibitors for malignant melanoma. Participants will be followed for six months after infusion while continuing a corticosteroid taper. The trial will compare signals of clinical benefit against expectations from standard corticosteroid treatment alone, with regular follow-up visits to monitor safety and irAE outcomes. Eligible patients are adults with histologically confirmed melanoma, currently treated with anti-PD-1/PD-L1/CTLA-4/other agents, and experiencing irAEs of grade 2–4. Exclusion criteria include infectious diseases, significant hematologic abnormalities, certain cardiovascular conditions, low IgG, and active HIV/HBV/HCV or TB infection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Where it's running

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

Study contacts

• Study coordinator: Inge Marie Svane, Professor, MD, PhD
• Email: inge.marie.svane@regionh.dk
• Phone: 004538683868

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Chidamide, Lenalidomide, and Rituximab as induction therapy for newly diagnosed elderly or unfit double-expressor DLBCL

  This trial tests whether the combo of chidamide, lenalidomide, and rituximab can help treat newly diagnosed double-expressor DLBCL in people who are elderly or not fit for standard chemotherapy.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07884708

• Rituximab plus Cyclosporine for Primary Membranous Nephropathy

  This study tests whether adding Cyclosporine to Rituximab helps people with primary membranous nephropathy achieve remission of heavy protein in the urine faster.

  Recruiting Phase 2/3 Peking University First Hospital · Beijing · NCT07861204

• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

  This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.

  Recruiting Phase 3 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality · NCT07808827

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• Tafasitamab and Rituximab for newly diagnosed follicular lymphoma

  This study tests a combination of tafasitamab and rituximab to treat adults with newly diagnosed follicular lymphoma.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07731789

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.