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Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma

Primary Purpose

Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
External Beam Radiation Therapy
Laboratory Biomarker Analysis
Pembrolizumab
Radiation Therapy
Temozolomide
Therapeutic Conventional Surgery
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological confirmation of supratentorial glioblastoma (also known as astrocytoma grade IV, gliosarcoma)
  • Neoadjuvant patients only: 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 biopsy or surgery

    • NOTE: Biopsy or subtotal resection must have been =< 43 days prior to registration
  • Neoadjuvant patients only: Willing to undergo craniotomy and resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN)
  • Adjuvant patients only: Must have undergone craniotomy and resection of their glioblastoma =< 6 weeks prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 28 days prior to registration)
  • Platelet count >= 100,000/mm^3 (obtained =< 28 days prior to registration)
  • Hemoglobin >= 9.0 g/dL without transfusion or erythropoietin (EPO) dependency (=< 7 days prior to assessment) (obtained =< 28 days prior to registration)
  • 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 (obtained =< 28 days prior to registration)
  • 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 (obtained =< 28 days prior to registration)
  • Albumin >= 2.5 mg/dL (obtained =< 28 days prior to registration)
  • Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (obtained =< 28 days prior to registration)
  • Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULN (obtained =< 28 days prior to registration)
  • Creatinine =< 1.0 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be >= 60 ml/min (obtained =< 28 days prior to registration)
  • 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 persons
    • Nursing persons
    • Persons of childbearing potential who are unwilling to employ adequate contraception
  • Neoadjuvant patients only: 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; NOTE: 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
  • Received or planning to receive Optune device

Sites / Locations

  • Mayo Clinic Hospital in Arizona
  • Mayo Clinic in Arizona
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 (pembrolizumab, surgery, temozolomide, radiation)

Group 2 (pembrolizumab, temozolomide, radiation therapy )

Arm Description

NEOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1. SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7. CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.

CONCURRENT (CYCLE 1): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLES 2-6): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 of cycles 2-5 and 1 and 22 of cycle 6 (up to a total of 17 doses). Patients also receive temozolomide PO daily on days 1-5, 29-33, and 57-61 of cycles 2 and 6, days 22-26 and 50-54 of cycle 3, days 15-19 and 43-47 of cycle 4, days 8-12 and 36-40 of cycle 5. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities (DLT) (Group 1)
A DLT will be defined as an adverse event attributed (definitely, probably, or possibly) to pembrolizumab per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The rate of DLTs within each dose-level cohort will be reported along with confidence intervals.
Overall survival (OS) (Group 2)
Will be defined as the number of patients who are alive up to 18 months after beginning study therapy divided by the total evaluable patients. The OS at 18 months percentage and 95% confidence intervals will be calculated via the Kaplan-Meier method.

Secondary Outcome Measures

Incidence of adverse events
The number and severity of all adverse events will be tabulated and summarized in this patient population. Specifically, the overall toxicity percentages for Grade 3 or higher adverse events considered at least possibly related to treatment will also calculated and reported. All other adverse event analysis will be exploratory and hypothesis generating. This may include and not be limited to: a summary of nonhematologic (unspecified) adverse events will be evaluated via the ordinal CTCAE grading, measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTCAE grading, overall adverse event incidence as well as profiles by dose level and by tumor type will be explored and summarized.
Time until any treatment related adverse event
Will be summarized descriptively.
Time until treatment related grade 3+ adverse event
Will be summarized descriptively.
Time until hematologic nadirs
Will assess the time until hematologic nadirs (white blood cell count, absolute neutrophil count, platelets) and will be summarized descriptively.
Time to progression (Group 2)
Will be assessed using the immunotherapy response assessment for neuro-oncology (iRANO) criteria. The median and 95% confidence intervals will be calculated via the Kaplan-Meier method.
Progression-free survival (Group 2)
Will be assessed according to iRANO criteria. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator.
Time to treatment failure (Group 2)
The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator.

Full Information

First Posted
June 21, 2017
Last Updated
September 29, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03197506
Brief Title
Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma
Official Title
Phase II Study of Pembrolizumab (MK-3475) in Combination With Standard Therapy for Newly Diagnosed Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
Temporary closure per protocol design
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. 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. Drugs used in the chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of pembrolizumab in combination with standard therapy (surgery, external beam radiation therapy and temozolomide [TMZ] chemotherapy) in patients with newly diagnosed glioblastoma multiforme (GBM). (Neoadjuvant [Group 1]) II. To assess the 18 month overall survival rate of pembrolizumab in combination with standard therapy (surgery, external beam radiation therapy and TMZ chemotherapy) in patients with newly diagnosed glioblastoma multiforme (GBM). (Adjuvant [Group 2]) SECONDARY OBJECTIVES: I. To assess adverse events (AE) and toxicity profile of pembrolizumab in combination with standard therapy in patients with newly diagnosed GBM. II. To assess time to progression in patients treated with pembrolizumab in combination with standard therapy in patients with newly diagnosed GBM. (Adjuvant only) III. To assess progression-free survival in patients treated with pembrolizumab in combination with standard therapy in patients with newly diagnosed GBM. (Adjuvant only) IV. To assess time to treatment failure in patients treated with pembrolizumab in combination with standard therapy in patients with newly diagnosed GBM. (Adjuvant only) CORRELATIVE RESEARCH OBJECTIVES: I. To assess the tumor PD-1/PD-L1 expression and inflammatory microenvironment profile by comparing PD-1/PD-L1 expression and T lymphocyte/monocytic infiltrates before and after administration of pembrolizumab treatment. (Neoadjuvant only) II. To assess the peripheral immunophenotype profile and GBM-associated antigen-specific T cell responses before and after receiving pembrolizumab treatment in combination with standard therapy. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP 1: NEOADJUVANT (CYCLE 1): Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7. CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide orally (PO) daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity. GROUP 2: CONCURRENT (CYCLE 1): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLES 2-6): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 of cycles 2-5 and 1 and 22 of cycle 6 (up to a total of 17 doses). Patients also receive temozolomide PO daily on days 1-5, 29-33, and 57-61 of cycles 2 and 6, days 22-26 and 50-54 of cycle 3, days 15-19 and 43-47 of cycle 4, days 8-12 and 36-40 of cycle 5. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months until progressive disease, then every 6 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (pembrolizumab, surgery, temozolomide, radiation)
Arm Type
Experimental
Arm Description
NEOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1. SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7. CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
Arm Title
Group 2 (pembrolizumab, temozolomide, radiation therapy )
Arm Type
Experimental
Arm Description
CONCURRENT (CYCLE 1): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLES 2-6): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 of cycles 2-5 and 1 and 22 of cycle 6 (up to a total of 17 doses). Patients also receive temozolomide PO daily on days 1-5, 29-33, and 57-61 of cycles 2 and 6, days 22-26 and 50-54 of cycle 3, days 15-19 and 43-47 of cycle 4, days 8-12 and 36-40 of cycle 5. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation
Intervention Description
Undergo external beam radiation therapy
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, Lambrolizumab, MK-3475, SCH 900475
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo surgery
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicities (DLT) (Group 1)
Description
A DLT will be defined as an adverse event attributed (definitely, probably, or possibly) to pembrolizumab per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The rate of DLTs within each dose-level cohort will be reported along with confidence intervals.
Time Frame
Up to 189 days (3 cycles of treatment)
Title
Overall survival (OS) (Group 2)
Description
Will be defined as the number of patients who are alive up to 18 months after beginning study therapy divided by the total evaluable patients. The OS at 18 months percentage and 95% confidence intervals will be calculated via the Kaplan-Meier method.
Time Frame
Beginning of study therapy to death, assessed at 18 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
The number and severity of all adverse events will be tabulated and summarized in this patient population. Specifically, the overall toxicity percentages for Grade 3 or higher adverse events considered at least possibly related to treatment will also calculated and reported. All other adverse event analysis will be exploratory and hypothesis generating. This may include and not be limited to: a summary of nonhematologic (unspecified) adverse events will be evaluated via the ordinal CTCAE grading, measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTCAE grading, overall adverse event incidence as well as profiles by dose level and by tumor type will be explored and summarized.
Time Frame
Up to 5 years
Title
Time until any treatment related adverse event
Description
Will be summarized descriptively.
Time Frame
Up to 5 years
Title
Time until treatment related grade 3+ adverse event
Description
Will be summarized descriptively.
Time Frame
Up to 5 years
Title
Time until hematologic nadirs
Description
Will assess the time until hematologic nadirs (white blood cell count, absolute neutrophil count, platelets) and will be summarized descriptively.
Time Frame
Up to 5 years
Title
Time to progression (Group 2)
Description
Will be assessed using the immunotherapy response assessment for neuro-oncology (iRANO) criteria. The median and 95% confidence intervals will be calculated via the Kaplan-Meier method.
Time Frame
From start of study treatment to progression, assessed up to 5 years
Title
Progression-free survival (Group 2)
Description
Will be assessed according to iRANO criteria. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator.
Time Frame
From date of starting study treatment to the date of disease progression or death resulting from any cause, whichever comes first, assessed up to 5 years
Title
Time to treatment failure (Group 2)
Description
The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator.
Time Frame
Time from beginning study therapy to documentation of progression, unacceptable adverse event(s), or refusal to continue participation by the patient, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Histological confirmation of supratentorial glioblastoma (also known as astrocytoma grade IV, gliosarcoma) NOTE: Grade IV IDH-mutant astrocytoma is also allowed Neoadjuvant patients only: 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 or astrocytoma from a prior biopsy or surgery NOTE: Biopsy or subtotal resection must have been =< 43 days prior to registration Neoadjuvant patients only: Willing to undergo craniotomy and resection of their brain tumor at Mayo Clinic in Rochester, Minnesota (MN) Adjuvant patients only: Must have undergone craniotomy and resection of their brain tumor =< 6 weeks prior to registration Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 28 days prior to registration) Platelet count >= 100,000/mm^3 (obtained =< 28 days prior to registration) Hemoglobin >= 9.0 g/dL without transfusion or erythropoietin (EPO) dependency (=< 7 days prior to assessment) (obtained =< 28 days prior to registration) 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 (obtained =< 28 days prior to registration) 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 (obtained =< 28 days prior to registration) Albumin >= 2.5 mg/dL (obtained =< 28 days prior to registration) Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (obtained =< 28 days prior to registration) Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULN (obtained =< 28 days prior to registration) Creatinine =< 1.0 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be >= 60 ml/min (obtained =< 28 days prior to registration) 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 persons Nursing persons Persons of childbearing potential who are unwilling to employ adequate contraception Neoadjuvant patients only: 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; NOTE: 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 Received or planning to receive Optune device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian F Parney
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma

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