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
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
History of grade 4 irAE (attributed to ICI per CTCAE v6.0)
History of cardiovascular or neurologic immune related adverse event
Active or serious infections
History of latent Tuberculosis (TB) or uncontrolled hepatitis B/C
Single group
Sarilumab
DrugSarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks.
ICI Therapy
DrugICI 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.
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
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Sanofi-Regeneron
Collaborator
Bristol-Myers Squibb
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
