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

NCT04220892 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-07-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pembrolizumab

200 mg intravenous (IV) every 3 weeks

DRUG

Pemetrexed

900 mg/m\^2 IV every 3 weeks. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.

DRUG

Abemaciclib

150 mg twice a day, by mouth.

Sponsors & Collaborators

Principal Investigators

  • Jose A Carrillo, MD · Saint John's Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2020-07-08
Completion
2020-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220892 on ClinicalTrials.gov