drugset / Trial / NCT04220892

Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for High Grade Glioma

NCT04220892

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate any preliminary evidence of anticancer activity of pembrolizumab combined with either pemetrexed or abemaciclib when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma. Additional aims of the study are to: * Find out the side effects (good and bad) of pembrolizumab combined with pemetrexed or abemaciclib; * • Evaluate tumor characteristics by collecting brain tumor tissue samples. * Measure the amount of pembrolizumab, pemetrexed, and/or abemaciclib that gets in the body by collecting blood and cerebrospinal fluid. * Look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug) in blood and cerebrospinal fluid if available.

Timeline

Start
2020-07-08
Primary completion
2020-07-08
Completion
2020-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 150 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pemetrexed Small molecule 900 mg/m2 Intravenous