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NCT07836101
Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events
Conditions: Any Advanced Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 41
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
Summary
The study will enroll patients with history of malignancy treated with immune checkpoint inhibitors (ICI) that have developed a grade 2 or higher immune related adverse event requiring treatment discontinuation as deemed by the patient's treating physician. Patients will be sequentially enrolled into the single-arm study after meeting the pre-specified eligibility criteria
Eligibility Criteria
Inclusion Criteria:
* Eligible patients include patients with malignancy treated with ICI, who have been diagnosed with a clinically significant irAE (grade 1-3 attributed to ICI per CTCAE v6.0) requiring interruption of ICI by the treating physician. This study is limited to patients with the following specific irAEs as IL-6R blockade has demonstrated effectiveness in these conditions. Specific toxicities eligible for inclusion are; arthritis, colitis, PMR, nephritis, pneumonitis, hepatitis, myositis
* The risk/benefit profile must favor ICI rechallenge as deemed per treating oncologist
* The irAE must have improved to grade 1 by CTCAE criteria v6.0 for at least 1 week (exception for patients who have endocrinopathies which will typically require lifelong hormone supplementation)
* Be willing and able to provide informed consent/assent for the trial
* Be ≥18 years of age on the day of signing informed consent
* Female subject of childbearing potential must have a negative urine or serum pregnancy test within 2 weeks prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Women of child-bearing potential (WOCBP):
* Agree to use contraception while participating in this study, and for a period of 6 months following last dose of Sarilumab or ICI, as effects of these agents on the developing human fetus are unknown. Men whose partner is a WOCBP must also agree to use contraception during this period. Negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within two weeks of registration. Women must not be breastfeeding or plan to breastfeed for the duration of therapy or 6 months after.
* Males must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 3 months after last dose of sarilumab, 120 days even if he has undergone a successful vasectomy
* Have adequate organ function as described below
* Absolute neutrophil count (ANC) ≥500/mm3
* Platelets ≥ 50,000/mm3
* AST/ALT \3xULN; total bilirubin \>1.5xULN)
* Significant hematological abnormalities
* On prednisone equivalent \>10mg prior to first dose of trial treatment
* History of immunodeficiency disorder
* Treatment with a non-biologic immunosuppressive or immune-modulating drug (e.g. methotrexate, azathioprine, mycophenolate, cyclosporine, hydroxychloroquine, penicillamine) at time of enrollment
* Treatment with other immune-modulating biologic agents (e.g TNF-alpha inhibitors) within 8 weeks prior to enrollment
* History of anaphylaxis or IgE-mediated hypersensitivity to sarilumab or history of allergic reactions attributed to compounds of similar chemical or biologic composition to sarilumab.
* The subject must meet all of the inclusion criteria and none of the exclusion criteria.
No eligibility waivers will be granted.
Source: ClinicalTrials.gov (NCT07836101). StuddyBuddy aggregates publicly available trial information.