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 |
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.
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
9
sites
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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