A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:August 2014
End Date:February 2017

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A PHASE 1B STUDY OF THE 4-1BB AGONIST PF-05082566 IN COMBINATION WITH THE PD-1 INHIBITOR MK-3475 IN PATIENTS WITH ADVANCED SOLID TUMORS

This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum
tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a
4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in
patients with solid tumors.


Inclusion Criteria:

- Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy
which has progressed on standard therapy or for which no standard therapy is
available.

- Measurable disease per RECIST v1.1.

- Adequate bone marrow, renal and liver functioning

Exclusion Criteria:

- CNS primary malignancies, active seizure disorder or spinal cord compression, or
carcinomatous meningitis.

- 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).
We found this trial at
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sites
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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New Haven, Connecticut 06520
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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