NCT03661723

Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma

Phase II Trial of Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying pembrolizumab and re-irradiation as possible treatments for glioblastoma. The drugs involved in this study are: * Pembrolizumab * Radiation * Bevacizumab, an FDA-approved drug for treating recurrent glioblastoma multiforme (GBM)

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. How the Study Interventions work: Pembrolizumab: Pembrolizumab has been studied in lab experiments and in other types of cancer, and information from these studies suggests that it may be beneficial in this type of cancer. Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this specific disease but it has been approved for other uses. Radiation (Re-irradiation): Radiotherapy destroys cancer cells using radiation aimed at a cancer from a machine. The FDA (the U.S. Food and Drug Administration) has approved re-irradiation as a treatment option for this disease. Bevacizumab: Bevacizumab (also known as "Avastin") is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. The FDA (the U.S. Food and Drug Administration) has approved bevacizumab as a treatment option for this disease. In this research study, the investigators are looking to determine if this combination (pembrolizumab + re-irradiation) proves helpful in treating this cancer. If the participant has already been receiving bevacizumab, the participant will continue to receive this along with pembrolizumab and re-irradiation. By doing this, the investigators will look to determine if this combination (pembrolizumab and bevacizumab + re-irradiation) proves helpful in treating this cancer. This study will also test the safety and tolerability of this combination (pembrolizumab + re-irradiation) when given alone or with bevacizumab

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
DRUG	Bevacizumab	Bevacizumab (also known as "Avastin") is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
RADIATION	Re-irradiation	Radiotherapy destroys cancer cells using radiation aimed at a cancer from a machine

Timeline

• Start date: 2018-09-28
• Primary completion: 2021-12-09
• Completion: 2024-08-01
• First posted: 2018-09-07
• Last updated: 2024-09-19
• Results posted: 2023-04-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study