A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
NCT ID: NCT02444793
Last Updated: 2019-02-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2015-05-31
2017-10-31
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 + KW-0761
During Parts 1 \& 2 Mogamulizumab and PF-05082566 will be administered at appropriate intervals. Part 1: PF-05082566 dose escalation; increased doses of PF-05082566 IV are administered with mogamulizumab IV. Part 2: patients will be treated with the maximum tolerated dose established in Phase 1 for the combination.
PF-05082566
Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.
KW-0761
Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.
Interventions
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PF-05082566
Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.
KW-0761
Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease by RECIST version 1.1.
* For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred).
* Age 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow, renal and liver function.
* Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.
* Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.
Exclusion Criteria
* Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.
* Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed.
* Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration.
* Live vaccine within 30 days prior to registration.
* Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation.
* History of autoimmune disease or known inflammatory bowel disease.
* Uncontrolled hypertension (blood pressure \>150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval \>470 msec.
18 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Michael J Pishvaian, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Esra E Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Dale R Shepard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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UC San Diego Moores Cancer Center
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
University of California San Diego Moores Cancer Center
La Jolla, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Georgetown University
Washington D.C., District of Columbia, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Henry Ford Hospital Research Pharmacy
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
UNC Cancer Hospital Infusion Pharmacy
Chapel Hill, North Carolina, United States
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Sanford Cancer Center
Sioux Falls, South Dakota, United States
Sanford Research
Sioux Falls, South Dakota, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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References
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Cohen EEW, Pishvaian MJ, Shepard DR, Wang D, Weiss J, Johnson ML, Chung CH, Chen Y, Huang B, Davis CB, Toffalorio F, Thall A, Powell SF. A phase Ib study of utomilumab (PF-05082566) in combination with mogamulizumab in patients with advanced solid tumors. J Immunother Cancer. 2019 Dec 4;7(1):342. doi: 10.1186/s40425-019-0815-6.
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.
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Other Identifiers
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B1641004
Identifier Type: -
Identifier Source: org_study_id
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