drugset / Trial / NCT07836101
Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events
Phase 2
Not yet recruiting
41 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb · collabSanofi-Regeneron · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2026-10
- Primary completion
- 2029-08
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sarilumab | Monoclonal antibody | 200 mg | Subcutaneous |