Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a single rituximab infusion tame Immunotherapy's harsh side effects?

NCT ID NCT07694414

Disease control Sponsor: Inge Marie Svane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This trial investigates whether a single ultra-low dose of rituximab can safely manage immune-related side effects caused by checkpoint inhibitor therapy in people with malignant melanoma. Participants receive one 100 mg infusion of rituximab along with a steroid tapering plan and are followed for six months. The study focuses on safety and whether rituximab helps control symptoms better than steroids alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab
What this could lead to
If successful, this could offer a safer, faster way to control severe immune side effects from cancer immunotherapy, reducing reliance on steroids.
What could go wrong
This is a small early-phase trial, so results may not apply broadly. Rituximab carries risks like infusion reactions and increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Immune-related adverse events are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune-related adverse events

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Herlev, Herlev, 2730, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.