Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
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 * Th…
Sarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks.
ICI will be administered on day 1 of each 3 or 4 week cycle depending on the selected ICI agent. Administration of ICI will continue past the 24 week timepoint per discretion of the investigator.
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