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Ivarmacitinib in Advanced Solid Tumors: A Prospective, Two-Cohort, Two-Phase Exploratory Study in Patients Discontinued Due to Immune Intolerance

ConditionPatients With Advanced Solid Tumors Who Discontinued Treatment Due to irAE
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Cancer Hospital

About this trial

This study is a Phase II, two-cohort, multicenter, two-stage clinical trial. It plans to enroll 72 subjects with solid tumors who discontinued prior ICI therapy due to irAE. Cohort 1 enrolls subjects with irAE resistant to or dependent on corticosteroid therapy. Subjects in Cohort 1 who achieve ≤ Grade 1 irAE resolution following treatment may then enroll in Cohort 2. Cohort 2 enrolls subjects with irAE achieving ≤ Grade 1 resolution following treatment, and deemed eligible for ICI re-initiation by the investigator. Phase I is the safety run-in phase, enrolling 6 subjects per cohort. Phase II is the expansion phase, enrolling 30 subjects per cohort.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

ECOG performance status score 0-1.

Expected survival ≥ 12 weeks.

Solid tumor patients who have discontinued treatment with immune checkpoint inhibitors (ICIs).

Disqualifiers

1) Individuals with allergic diseases, a history of severe drug allergies, or potential hypersensitivity to Ivarmacitinib or its components; 2) Patients diagnosed with an embolic event within 3 months prior to enrollment, excluding superficial venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency); 3) Patients with severe non-irAE-related cardiac, hepatic, renal, or systemic diseases; 4) Patients with active tuberculosis or who received live vaccines during the illness period; 5) Patients with uncontrolled infectious diseases; 6) Patients with moderate to severe heart failure (NYHA Class III/IV); 7) Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) exceeding 500 IU/mL or 1000 copies per milliliter (cps/mL); Hepatitis C virus (HCV) antibody (HCV-Ab) positive with HCV RNA quantitative levels exceeding the upper limit of normal for the assay; HIV antibody (Anti-HIV) positive; active syphilis. Meeting any one of the above criteria.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ivarmacitinib

    Drug

    8 mg, orally, once daily. Cohort 1: Continue dosing until irAE resolves to ≤ Grade 1, with a maximum treatment duration of 28 days.

  • Ivarmacitinib

    Drug

    Cohort 2: Combination therapy with ICIs, with a maximum treatment duration not exceeding the duration of ICI administration.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Treatment group 1：Subjects who developed resistance or dependence to hormone therapyExperimental treatment 1 intervention
Group B: Treatment group 2：Subjects whose irAE has resolved to Grade ≤1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response rate to adverse reactions during the treatment cycle

Time frame
In the study, treatment was administered on day 30 after the last dose.
2

Discontinuation rate due to irAE

Time frame
Follow-up visits were conducted every 30 days from the last dose of treatment until 90 days.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: