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Promising drug for immunotherapy side effects never tested: trial withdrawn

NCT ID NCT05660421

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial aimed to test the drug itacitinib in people with severe side effects from cancer immunotherapy that did not get better with steroids. The goal was to see if itacitinib could calm the overactive immune response causing these side effects. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

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

Active substance
Itacitinib
What this could lead to
If it had worked, itacitinib could have offered a new treatment option for people with severe immunotherapy side effects that don't respond to steroids.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no data was collected. It is unknown if itacitinib is safe or effective for this use.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Mar 2023

Finished

Apr 2025

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: * Must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care. * Must be willing and able to comply with scheduled visits, treatment schedule,laboratory tests, biopsies, and other requirements of the study. * Must have received at least one immune checkpoint inhibitor (ICI) therapy either as single agent(s) or in combination(s), including but not limited to nivolumab, ipilimumab, pembrolizumab, cemiplimab, atezolizumab, durvalumab, or avelumab. * Must experience at least one Grade 2, 3 or 4 (CTCAE Version 5.0) toxicity/immune-related adverse event (irAE) attributed to immune checkpoint inhibitor (ICI) therapy as diagnosed by the patient's study physician. This may be established by clinical, histological, or imaging criteria as defined below: * Symptoms must be attributed to an immune-related adverse event (irAE), with no infectious or alternative cause suspected by the patient's study physician. * Must be actively experiencing Grade 2+ irAE (at the time of screening) as broadly defined below: * Cutaneous toxicity (including skin rash) * Colitis/enteritis (As defined by Grade 2+ diarrhea or Grade 2+ colitis (either or both conditions) * Pneumonitis * Arthritis * Hepatitis (As defined by Grade 2+ elevation in AST or ALT (either or both values elevated) * Nephritis (As defined by either Grade 2+ elevation in creatinine and/or proteinuria of at least 2+ on urinalysis attributed to ICI) * Myocarditis (Given the vague nature of symptomatic myocarditis grading, troponin levels will be primarily used to grade myocarditis,( Troponin \>2ng/ml), (Presumed diagnosis of myocarditis (myocardial infarction ruled out clinically) * Myositis (Defined as grade 2 myositis symptoms per CTCAE OR grade 2 elevations in creatinine kinase levels) * Neurologic toxicity * Encephalitis * Neurologic symptoms consistent with encephalitis * Lumbar puncture and infectious disease consult to rule out infectious etiologies if clinical suspicion for infectious causes * Guillain Barre * MRI performed to rule out spinal cord compression * Neurology consult to confirm diagnosis (or extremely high suspicion) * Myasthenia Gravis * MRI performed to rule out spinal cord compression and brain metastases * Neurology consult to confirm diagnosis (or extremely high suspicion) * Pericarditis * Vasculitis * Gastritis * Other toxicities * Other steroid refractory toxicities not listed in the above list * NOTE: Endocrine toxicities (including hypophysitis, hypopituitarism, hypothyroidism, thyrotoxicosis, immune checkpoint inhibitor-induced diabetes, and primary adrenal insufficiency) will NOT qualify for inclusion. * Must have received oral or intravenous corticosteroids of at least 50mg per day prednisone equivalent dosing (approximately 1mg/kg daily) for ≥ 48 hours of therapy with worsening or lack of improvement to Grade 2. * May have been treated with additional immunomodulators (one or more) prior to study entry (e.g. infliximab, mycophenolate mofetil, intravenous immunoglobulin), provided such immunomodulators are discontinued prior to first dose of study therapy. * Adequate organ and marrow function as defined below: * White blood cell (WBC) ≥ 2.0 ×109/L. * Neutrophil (ANC) ≥ 1.5 ×109/L. * Platelet (PLT) ≥ 75 ×109/L. * Hemoglobin (Hgb) ≥ 8.0 g/dL. * AST and ALT ≤ 3 x ULN in subjects without hepatic metastases; AST and ALT ≤ 5 x ULN in subjects with hepatic metastases, if AST/ALTelevation is NOT due to ICI-induced hepatitis; (Exception (without or with hepatic metastases): no limit for patients with ICI-induced hepatitis). * Total bilirubin ≤ 2 x ULN not due to ICI-hepatitis (except subjects with Gilbert syndrome, where total bilirubin must be \< 3.0 mg/dL), (Exception: no limit for patients with ICI-induced hepatitis). * Reproductive status: * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of study treatment. * Women must not be breastfeeding. * Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of study drug treatment and 60 days after the last dose of study treatment or longer if required based on prior immunotherapy received (for example, at least 4-5 months for nivolumab and pembrolizumab). * Males who are sexually active with Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of study treatment and 60 days after the last dose of study drug or longer if required based on prior immunotherapy received. * Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements but still must undergo pregnancy testing as described in this section. * Investigators shall counsel Women of childbearing potential, and male participants who are sexually active with Women of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception which have a failure rate of \< 1% when used consistently and correctly. Women of childbearing potential and men must agree to use adequate contraception (for example, hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of protocol treatment. Exclusion Criteria: * Toxicity deemed by patient's study physician to be primarily caused by another etiology (bacterial infection, other anticancer agents, etc.). * Ongoing serious infection requiring IV antibiotics. * Prior treatment with a JAK inhibitor within the past 8 weeks before first dose of protocol indicated treatment. * Known HIV infection with CD4 count \< 200. (Testing not required by this study.) * History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease, including any of the following: * Recent myocardial infarction (within 6 months before first dose of protocol indicated treatment). * New York Heart Association Class III or IV congestive heart failure. * Unstable angina (within last 6 months before first dose of protocol-indicated treatment). * Clinically significant (symptomatic) cardiac arrhythmias per judgment of patient's study physician (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker). * Uncontrolled hypertension defined as blood pressure persistently above 160 systolic or 100 diastolic despite antihypertensive therapy. * Known allergies, hypersensitivity, or intolerance to any study medications or excipients. * History of solid organ transplant or allogeneic stem cell transplant with active graft versus host disease. * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug/treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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