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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT02179918

Run by

Pfizer

People needed

23

Starts

2014-08-01

Expected to finish

2017-02-01

Last updated by the study team

2019-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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