Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2022-05-19
2023-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pembrolizumab with standard of care chemotherapy treatment
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
Pembrolizumab
Pembrolizumab is an immunotherapy that can help fight certain cancers.
Nab paclitaxel
Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
Paclitaxel
Paclitaxel is a taxane derivative that promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication.
Pemetrexed
Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
Carboplatin
Carboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links.
Interventions
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Pembrolizumab
Pembrolizumab is an immunotherapy that can help fight certain cancers.
Nab paclitaxel
Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
Paclitaxel
Paclitaxel is a taxane derivative that promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication.
Pemetrexed
Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
Carboplatin
Carboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NSLC lacks oncogenic driver mutations
* Absence of new onset neurological symptoms
* Presence of fewer than ten intracranial lesions
* Each lesion measures three centimeters or less
* Life expectancy of greater than three months
* Adequate organ and marrow function
* Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria
* Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem
* Known leptomeningeal involvement.
* Midline shift
* Serious non-healing wound, ulcer or bone fracture
* Baseline inability to participate or complete neurocognitive testing
* Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration
* Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration
* History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab
* Clinically significant cardiovascular disease
* Patients with uncontrolled intercurrent illness
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
18 Years
85 Years
ALL
No
Sponsors
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John L. Villano, MD, PhD
OTHER
Responsible Party
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John L. Villano, MD, PhD
Principal Investigator
Principal Investigators
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John Villano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MCC-21-NEURO-11
Identifier Type: -
Identifier Source: org_study_id
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