Pharmacodynamic Study of Pembrolizumab in Patients With Recurrent Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02337686|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : July 19, 2018
The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to control glioblastoma. The safety of this drug will also be studied.
This is an investigational study. Pembrolizumab is FDA approved and commercially available for the treatment of some types of melanoma. Its use against brain tumors in this study is investigational. The study doctor can explain how the study drug is designed to work.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Glioblastoma Cancer||Drug: Pembrolizumab Procedure: Surgery||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacodynamic Study of Pembrolizumab in Patients With Recurrent Glioblastoma|
|Actual Study Start Date :||April 28, 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Pembrolizumab 200 mg, intravenously (IV) once every 3 weeks prior to surgery for two doses and then restarting 200 mg every 3 weeks following surgical resection. Cycles defined as every 42 days.
Up to 2 doses of 200 mg IV prior to surgery (Day -21 and Day -1, prior to the surgery on Day 0); continued after recovery from surgery (approximately 2-3 weeks) every 3 weeks until disease progression or development of unacceptable toxicities.
Routine care surgery (reoperation) performed Day 0 for tumor progression.
- Progression free survival at 6 months [ Time Frame: Baseline to 6 months ]Progression-free survival defined as the time from study enrollment until the time of first occurrence of disease progression, relapse, or death due to disease.
- Immune Effector:Treg ratio measured at the time of surgery [ Time Frame: Measurement taken from tissue collected at time of surgery (Day 0) following 21 days of first treatment cycle ]Immune effector function measured in resected glioblastoma tissue after treatment with intravenously administered pembrolizumab monotherapy in the neoadjuvant setting in participants with recurrent glioblastoma. Pembrolizumab pharmacokinetics from blood correlated with tumor pharmacodynamic markers; Tumor tissue from surgical resection and peripheral blood evaluated longitudinally for pharmacodynamic effects including an increase of polyfunctional effector T cells:Treg ratio and improvement in the anti-tumor immune response. Defined Effector:Treg ratio>=5% is a success (i.e., favorable outcome) and <5% is a failure (i.e., unfavorable outcome).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337686
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||John DeGroot, MD||M.D. Anderson Cancer Center|