Pre-radiation Nivolumab plus Ipilimumab for High-Grade Gliomas
Study Overview
This study explores the use of immune checkpoint inhibitors (ICIs) before radiation therapy in patients with newly diagnosed high-grade gliomas. We conducted a phase I trial with patients receiving:
- Nivolumab: 300 mg every 2 weeks
- Ipilimumab: 1 mg/kg every 6 weeks
Treatment continued until disease progression or unacceptable side effects. A total of 15 patients participated, with treatment starting about 38 days after surgery.
Key Findings
The most common side effects included:
- Rash
- Itching
- Fatigue
- Nausea
- Loss of appetite
Serious side effects included:
- Grade 3: Increased lipase (2 patients), anorexia (1 patient), itching (1 patient), rash (3 patients)
- Grade 4: One case of cerebral edema
The median progression-free survival was 1.3 months, and the median overall survival was 19.3 months. Notably, three patients delayed standard treatment for over seven months.
Conclusion
This study shows that nivolumab plus ipilimumab can be safely given before standard radiation therapy for newly diagnosed gliomas. This approach is feasible and may offer new treatment options for patients.
Clinical Trial Registration
ClinicalTrials.gov NCT03425292 registered on February 7, 2018.
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