NCT05638451

Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients

Phase 2 Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma.

Detailed description

This is a phase 2,open-label, multicenter, single-arm study designed to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma. A total of 30 patients will be enrolled in the study and administered Sintilimab in combination with Bevacizumab and Temozolomide. The study treatment will be continued for up to 4 cycles and Sintilimab was maintained until a progression of disease or unacceptable toxicity is confirmed.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Sintilimab plus Bevacizumab and Temozolomide	200mg Sintilimab plus 10mg/kg Bevacizumab very 3 weeks 200 mg/m2/day Temozolomide on days 1-5 out of a 28 days schedule

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-12-06
• Last updated: 2024-06-05

Locations

1 site across 1 country: China