Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1
36 participants
INTERVENTIONAL
2018-11-27
2021-09-27
Brief Summary
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Part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the Expansion dose of VBIR-2 in participants with advanced or metastatic non-small cell lung cancer.
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Detailed Description
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Part 1 has been completed.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation (Part 1)
Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.
PF-06936308
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
Dose Expansion (Part 2)
Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.
PF-06936308
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
Interventions
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PF-06936308
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Part 2: Histological or cytological diagnosis of metastatic non-small cell lung cancer previously treated with 1 or 2 regimens in metastatic setting including a CPI and platinum-based chemotherapy. Adequate bone marrow, renal and liver function.
Exclusion Criteria
* ECOG performance status greater than or equal to 2
* Concurrent immunotherapy
* History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
* History of inflammatory bowel disease.
* Current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
* Presence of any surgical or traumatic metal implants at the site of administration
18 Years
ALL
No
Sponsors
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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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UCSD Medical Center - Encinitas
Encinitas, California, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
La Jolla, California, United States
UC San Diego Perlman Medical Offices
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
UCSD Medical Center - Vista
Vista, California, United States
H Lee Moffitt Cancer Center & Research Institute Inc
Tampa, Florida, United States
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
Orland Park - University of Chicago Center for Advanced Care
Orland Park, Illinois, United States
Horizon Oncology Research, LLC
Lafayette, Indiana, United States
InnerVision Advanced Medical Imaging
Lafayette, Indiana, United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute Downtown
Louisville, Kentucky, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Washington Medical Center - Translational Research Unit (TRU)
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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VBIR-2
Identifier Type: OTHER
Identifier Source: secondary_id
C3621001
Identifier Type: -
Identifier Source: org_study_id
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