NCT04118036

Abemaciclib + Pembrolizumab In Glioblastoma

A Phase 2 Study of Abemaciclib and Pembrolizumab in Recurrent Glioblastoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination therapy as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. This study will involve participants with recurrent glioblastoma at their first relapse enrolled in two arms including patients who require reoperation and patients not requiring surgery. This research study involves a combination of two drugs: * Pembrolizumab (MK3475) * Abemaciclib (LY2835219)

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. Many brain cancers show over expression of a protein called cyclin D1. That means that the body makes too much cyclin D1, which affects enzymes called CDK 4 and CDK 6. Enzymes are substances in the body that help reactions between cells happen. Too much cyclin D1 triggers CDK 4 and CDK 6 to make more cells than normal. This extra cell production leads to the growth of tumors. In laboratory studies, abemaciclib was able to enter the brain, stop CDK 4 and CDK 6 from making cells, and slow growth of glioblastoma in mice. Pembrolizumab (MK-3475) has been studied in lab experiments and in other types of cancer. Information from these studies suggests that Pembrolizumab (MK-3475) may be beneficial inrecurrent glioblastoma (GBM). Pembrolizumab (MK-3475) is a humanized monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. Antibodies can also be produced in the laboratory for use in treating patients; an antibody that is made in the lab is also known as a humanized monoclonal antibody that is designed to block the action of the receptor, PD-1. PD-1 works to help tumor cells continue to grow and multiply. There are now several approved antibodies for the therapy of cancer and other diseases. .

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	intravenously over 30 minutes every 21 days (+/- 3 days)
DRUG	Abemaciclib	Oral 2 times a day

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2019-10-07
• Last updated: 2025-08-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study