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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Safety as assessed by Absence of any grade ≥2 Immune Related Adverse Event (irAE)
Absence of any grade ≥2 Immune Related Adverse Event (irAE) in the 3 months after ICI rechallenge, defined as grade ≥2 adverse event attributed to ICI by CTCAE v6.0
Time frame: From enrollment to the end of treatment at 53 weeks
Safety and tolerability as assessed by occurrence of adverse events
Safety and tolerability will be measured by occurrence of grade ≥3 adverse events as measured by CTCAE v6.0 and patient reported outcomes (PROs) as assessed by PRO-CTCAE v1.0.
Time frame: From enrollment to the end of treatment at 53 weeks
Absence of Serious immune-related adverse event
To assess to the safety of Immune Checkpoint Inhibitor (ICI) rechallenge with sarilumab with respect to serious irAE of grade ≥2 in patients with a history of non- cardiovascular and non-neurologic clinically significant irAEs.
Time frame: From enrollment to the end of treatment at 53 weeks
Efficacy as assessed by progression free survival
Cancer outcomes will be measured by progression free survival (PFS). PFS is defined as the time from first dose of sarilumab + ICI rechallenge until investigator-assessed radiological progressive disease (PD) or death, whichever comes first.
Time frame: From enrollment to the end of treatment at 53 weeks
Efficacy as assessed by Overall survival
Cancer outcomes will be measured by overall survival (OS).Overall survival is defined as the time from first dose of sarilumab + ICI rechallenge until death.
Time frame: From enrollment to the end of treatment at 53 weeks
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