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Pembrolizumab in Treating Patients With Recurrent Glioblastoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Pembrolizumab in Treating Patients With Recurrent Glioblastoma

Pharmacodynamic Study of Pembrolizumab in Patients With Recurrent Glioblastoma

NCT02337686•M.D. Anderson Cancer Center

Summary

This phase II trial studies the effects of pembrolizumab on the body, or pharmacodynamics, in patients with glioblastoma that has come back. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate immune effector function in resected glioblastoma tissue after treatment with intravenously administered pembrolizumab monotherapy in the neoadjuvant setting in patients with recurrent glioblastoma. II. To correlate the progression free survival at 6 months (PFS6) with objective increases in the immune effector T cell: regulatory T cell (Treg) ratio in tumor tissue as measured by ex vivo T-cell-specific cytokines profiling. SECONDARY OBJECTIVES: I. Comparison of time to progression of last prior therapy to time to progression on pembrolizumab, median duration of response, overall response rate (ORR), and overall survival (OS) and safety. TERTIARY OBJECTIVES: I. To identify imaging characteristics associated with immunological changes in tumor following treatment with pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day -21 and day -1, and then undergo surgery on day 0. After 2-3 weeks or recovery from surgery, patients continue to receive pembrolizumab IV over 30 minutes every 3 weeks. Courses repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be willing and able to provide written informed consent/assent for the trial
•Patients must be at first or second relapse and clinically require reoperation for tumor progression within 4 to 6 weeks; Note: relapse is defined as progression following initial therapy (i.e., radiation, chemotherapy, or radiation + chemotherapy); if the participant had a surgical resection for relapsed disease and no anti-tumor therapy instituted for up to 12 weeks, this is considered one relapse; for participants who had prior therapy for a low grade glioma, the surgical diagnosis of a high grade glioma will be considered first relapse
•Have measurable disease consisting of a minimal volume of 1 cm\^3
•Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
•Have a performance status of \>= 60 on the Karnofsky performance scale (KPS)
•Stable dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day
•Absolute neutrophil count (ANC) \>= 1,500/mcL (performed within 14 days prior to registration)
•Platelets \>=100,000/mcL (performed within 14 days prior to registration)
•Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L (performed within 14 days prior to registration)
•Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN (performed within 14 days prior to registration)
+7 more criteria

Exclusion Criteria

•Has been treated previously with bevacizumab
•Has tumor localized primarily to the brainstem or spinal cord
•Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery
•Is currently participating in or has participated in a study of an investigational agent or using an investigational device 4 weeks since last dose of agent administration
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \> 2 mg of dexamethasone total per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
•Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent; Note: subjects with alopecia, =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
•Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
•Has known carcinomatous meningitis, extracranial disease, or multifocal disease
•Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
+9 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 28, 2015

Primary Completion Date

May 24, 2017

Completion Date

December 31, 2026

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent GlioblastomaRecurrent Gliosarcoma

Interventions

Laboratory Biomarker Analysis

OTHER

Pembrolizumab

BIOLOGICAL

Pharmacological Study

OTHER

Therapeutic Conventional Surgery

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pembrolizumab in Treating Patients With Recurrent Glioblastoma

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

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