Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03197506 : Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histological confirmation of supratentorial glioblastoma (also known as astrocytoma
grade IV, gliosarcoma) amenable to surgical resection =< 28 days prior to registration

- Have an enhancing mass on magnetic resonance imaging (MRI) amenable to > 90% resection
of contrast-enhancing tumor (as determined by the neurosurgeon pre-operatively) and
histological diagnosis of glioblastoma from a prior stereotactic biopsy

- Willing to undergo craniotomy and resection of their glioblastoma

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Absolute neutrophil count (ANC) >= 1500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 9.0 g/dL without transfusion or erythropoietin (EPO) dependency (=< 7
days prior to assessment)

- Prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless patient is receiving
anticoagulant therapy and PT or partial prothrombin time (PTT) is within therapeutic
range of intended use of coagulants

- Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless patient is receiving
anticoagulant therapy and PT or PTT is within therapeutic range of intended use of
coagulants

- Albumin >= 2.5 mg/dL

- Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total
bilirubin levels > 1.5 x ULN

- Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULN

- Creatinine =< 1.0 x ULN OR measured or calculated creatinine clearance (per
institutional standard) must be >= 60 ml/min

- Negative pregnancy test done =< 7 days prior to registration, for persons of
childbearing potential only (POCBP)

- NOTE: Serum or urine pregnancy test allowed; if urine test is positive or cannot
be confirmed as negative, a serum pregnancy test will be required

- POCBP must be willing to use adequate contraception starting with first dose through
120 days after last dose

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the active monitoring
phase of the study)

- Note: During the active monitoring phase of a study (i.e., active treatment and
observation), participants must be willing to return to the consenting
institution for follow-up

- Willing to provide tissue and blood samples for correlative research purposes

Exclusion Criteria:

- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception

- Signs or symptoms of life-threatening raised intracranial pressure: as defined by the
treating neurosurgeon, including severe headache, nausea, decreasing level of
consciousness, precluding 4-7 day delay in scheduling neurosurgery

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm

- Other active malignancy =< 5 years prior to registration

- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix

- NOTE: If there is a history or prior malignancy, the patient must not be
receiving other specific treatment for their cancer

- History of myocardial infarction =< 6 months prior to registration, or congestive
heart failure requiring use of ongoing maintenance therapy for life-threatening
ventricular arrhythmias

- Active autoimmune disease that has required systemic treatment in the past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive
drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment

- Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or
hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is
detected)

- Known history of active TB (Bacillus tuberculosis)

- Received a live vaccine =< 30 days prior to registration

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis

- Hypersensitivity to pembrolizumab or any of its excipients

- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03197506      |      Link to official Clinicaltrials.gov listing
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