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

Conditions

• Any Advanced Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

First listed

Sep 23, 2026

Start date

Oct 31, 2026

Status verified

Sep 2026

Primary completion

Aug 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

41 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sarilumab with ICI
  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.

Primary Outcome Measure

Safety as assessed by Absence of any grade ≥2 Immune Related Adverse Event (irAE) [ Time Frame: From enrollment to the end of treatment at 53 weeks ]

Central Contacts

• Danielle Wendler
  410-502-5140
  [email protected]
• Chelsea Miralles
  410-955-9923
  [email protected]

Locations (1)

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