A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
NCT ID: NCT02179918
Last Updated: 2019-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2014-08-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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PF-05082566 +MK-3475
PF-05082566 +MK-3475
PF-05082566
Starting dose of 0.45 mg/kg q3wks IV, dose escalation
MK-3475
2 mg/kg q3wks, IV
Interventions
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PF-05082566
Starting dose of 0.45 mg/kg q3wks IV, dose escalation
MK-3475
2 mg/kg q3wks, IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease per RECIST v1.1.
* Adequate bone marrow, renal and liver functioning
Exclusion Criteria
* History of any of the following toxicities associated with a prior immunotherapy:
* Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;
* Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy
* Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
* History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).
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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Research Administration Office
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States
UCLA Oncology Center
Los Angeles, California, United States
Smilow Cancer Center at Yale-New Haven Hospital
New Haven, Connecticut, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
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-0036
Identifier Type: -
Identifier Source: secondary_id
B1641003
Identifier Type: -
Identifier Source: org_study_id
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