Immune-Related Adverse EventsPhase 1RiTOXNCT07694414
Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
A Phase 1 study testing Rituximab (RTX) in people with Immune-Related Adverse Events, run by Inge Marie Svane at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-Related Adverse Events
- What is being tested?
- Rituximab (RTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2026to 1 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital
Herlev, Herlev, 2730
Frederikke Strauss Hansen, MD, PhD-student, 004538683868, frederikke.strauss.hansen@regionh.dk
frederikke.strauss.hansen@regionh.dk
About this study
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
- Being tested
- Rituximab (RTX)
- Keywords
- Rituximab, Immunotherapy, Checkpoint inhibitors, Malignant melanoma, Immune-related adverse event
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab (RTX)Drug
A single ultra-low dose rituximab (100 mg) infusion for patients with immune-related adverse events
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Not described Receives: Drug: Rituximab (RTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 6 months post treatment
Secondary outcomes (4)
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)
Measured: Until 6 months post treatment
Corticosteroid dependency
Corticosteroid dependency in rituximab treated patients measured as the number of days on corticosteroids following rituximab infusion.
Measured: Until 6 months post treatment
Dose of corticosteroids
Assessment of rituximab efficacy measured as cumulative dose and peak dose of corticosteroids.
Measured: Until 6 months post treatment
Second- or third-line immunosuppressants
Assessment of rituximab efficacy measured as the proportion of patients requiring second- or third-line immunosuppressive therapy after rituximab
Measured: Until 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Oct 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-Related Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694414
- Sponsor's protocol ID
- AA2603
- Other IDs
- 2026-525728-18-00
- Acronym
- RiTOX
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No