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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA256421 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab with stereotactic radiation therapy and surgical resection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events. | Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0. | From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years. |
| Overall survival | From start of study treatment until death, loss to follow-up, or withdrawal of consent. Subjects who are lost to survival follow-up will not be replaced, and public records may be accessed to assess Overall Survival. | From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | From start of study treatment until confirmation of disease progression (per iRANO Criteria), intolerable toxicities, withdrawal of consent, or up to 2 years or 18 cycles of pembrolizumab, whichever comes first. | From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
Complete inclusion/exclusion criteria are detailed in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Recruitment Navigator | Contact | 3104232133 | cancer.trial.info@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Chirag G Patil, MD, MS | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2022 | Oct 5, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| D013120 | Spinal Cord Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Stereotactic Radiation Therapy | Radiation | Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7 |
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| Surgical Resection | Procedure | Standard of care surgical resection of tumor on Day 10-28 |
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| Immune action | To assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment. Blood draws for research purposes performed after obtaining consent but prior to neoadjuvant pembrolizumab administration, and at the time of initiation of SRT and at the time of surgery | At baseline, prior to stereotactic radiation therapy, and prior to surgery. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |