A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:September 2014
End Date:February 2019

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A Phase 1b, Open Label, Dose Finding Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of Axitinib (Ag-013736) In Combination With Pembrolizumab (Mk-3475) In Patients With Advanced Renal Cell Cancer

Despite substantial improvements of patients outcome in advanced RCC, durable and complete
response is uncommon. The majority of patients eventually develop resistance and exhibit
disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with
axitinib may provide additional clinical benefit compared to axitinib alone.


Inclusion Criteria:

- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell
subtype with primary tumor resected

- At least one measureable lesion as defined by Response Evaluation Criteria In Solid
Tumors (RECIST) version 1.1.

- Eastern Cooperative Oncology Group performance status 0 or 1

- Controlled hypertension

Exclusion Criteria:

- Prior treatment with systemic therapy for advanced RCC

- Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred
during or within 12 months after the last dose of treatment

- Prior treatment with any agent specifically targeting T-cell co-stimulation or
checkpoint pathways

- Active seizure disorder or evidence of brain metastases, spinal cord compression, or
carcinomatous meningitis

- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of
randomization except for adequately treated basal cell or squamous cell skin cancer,
or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with
no plans for treatment intervention

- In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
or transient ischemic attack

- In past 6 months: deep vein thrombosis or pulmonary embolism
We found this trial at
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Nashville, Tennessee 37232
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Columbus, OH
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Columbus, Ohio 43210
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Columbus, Ohio 43210
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Columbus, Ohio 43221
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Detroit, Michigan 48201
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New York, New York 10016
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New York, New York 10016
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Philadelphia, Pennsylvania 19111
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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