Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
NCT ID: NCT02511184
Last Updated: 2019-07-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2015-10-31
2017-12-31
Brief Summary
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Detailed Description
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In the dose finding phase, patients who meet eligibility criteria will receive crizotinib at the dose level assigned that will be taken on daily basis and pembrolizumab 200 mg intravenous infusion every 3 weeks.
Once a Crizotinib dose level is decided, the dose expansion cohort will start enrolling patients who meet eligibility criteria.
All patients will be followed up every three weeks. Blood samples will be drawn to test for safety and tumor activities and radiological scans will be performed on certain timepoints to determine the antitumor activities.
There will be a quality of life questionnaire administered at certain time points during the study.
The study will have a quality assurance plan that addresses data validation and registry procedures. There is a plan to visit the investigator site for routine monitoring and auditing.
The team will conduct source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
The study will also include a statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives of this study, as specified in the study protocol or statistical plan.
Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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Dose finding and dose expansion phases
Find and expand the maximum tolerated dose of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks.
Crizotinib
To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks
Pembrolizumab
To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.
Interventions
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Crizotinib
To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks
Pembrolizumab
To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.
Eligibility Criteria
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Inclusion Criteria
* Alk-positive NSCLC as determined by a test that is approved or validated for use as a companion diagnostic test.
* No prior systemic therapy for metastatic disease.
* Adjuvant chemotherapy more than 12 months prior to study enrollment.
* Measurable disease as per RECIST 1.1
* ECOG PS 0 or 1.
Exclusion Criteria
* known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
* Active autoimmune disease that has required systemic treatment in the past 3 months.
* History of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla, California, United States
UC San Diego Medical Center - La Jolla(Thornton Hospital)
La Jolla, California, United States
University Of California / San Diego Moores Cancer Center
La Jolla, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Swedish Cancer Institute
Seattle, Washington, United States
Swedish Investigational Drug Services Pharmacy
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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KEYNOTE 050
Identifier Type: OTHER
Identifier Source: secondary_id
CRIZOTINIB
Identifier Type: OTHER
Identifier Source: secondary_id
A8081054
Identifier Type: -
Identifier Source: org_study_id
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