Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events

NCT07836101 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: J268715845IRB00559848
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Any Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment at 53 weeks

Secondary Outcomes (4)

• Safety and tolerability as assessed by occurrence of adverse events

  From enrollment to the end of treatment at 53 weeks

• Absence of Serious immune-related adverse event

  From enrollment to the end of treatment at 53 weeks

• Efficacy as assessed by progression free survival

  From enrollment to the end of treatment at 53 weeks

• Efficacy as assessed by Overall survival

  From enrollment to the end of treatment at 53 weeks

Study Arms (1)

Sarilumab with ICI

EXPERIMENTAL

Sarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks. ICI will be dosed by investigator's choice per standard of care for malignancy. 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.

Drug: Sarilumab; Drug: ICI Therapy

Interventions

Sarilumab DRUG

Sarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks.

Sarilumab with ICI

ICI Therapy DRUG

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.

Sarilumab with ICI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<=3× institutional upper limit of normal
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Completed informed consent process, including signing Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form.
• Willing and able to comply with clinical trial instructions and requirements. Subjects must be competent to report AEs, understand the drug dosing schedule, and use of medications to control AEs

You may not qualify if:

• 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
• History of gastrointestinal perforation or diverticulitis
• Severe hepatic impairment (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.
• No eligibility waivers will be granted.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Sanofi-Regeneron: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

sarilumab

Study Officials

• Aliyah Pabani, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Wendler

CONTACT

410-502-5140; JHCTN@jhmi.edu

Chelsea Miralles

CONTACT

410-955-9923; cmirall1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, single-arm phase 2 clinical trial evaluating the safety of sarilumab with ICI rechallenge in patients with a history of a clinically significant immune related adverse event.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)