Kidney Cancer Clinical Trial
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
Summary
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.
Eligibility Criteria
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
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There are 13 Locations for this study
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10016, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43221, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37232, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
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