NCT05700955

Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma

A Phase I Trial of Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to test the safety of Pembrolizumab and Temozolomide in treating recurrent glioblastoma and to characterize the effect of this treatment on the participants tumor and immune system..

Detailed description

Participants will undergo screening tests to determine if they are eligible to participate. This will involve a complete history and physical examination, vital signs, blood tests including complete blood count (CBC), and serum chemistry (CMP). Participants will receive one cycle of Temozolomide and Pembrolizumab prior to removing recurrent tumor, followed by three weekly cycles of treatment until progression.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab and Temozolomide	Characterize the safety and immunologic/genomic/metabolomic effects of neoadjuvant Pembrolizumab and Temozolomide in recurrent glioblastoma.

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study