Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who have already received some treatment. It works by reducing blood flow to a tumor. Axitinib is normally give at 5mg twice per day and sometimes this dose is increased if patients tolerate it. The purpose of this study is to figure out a different way to decide which dose of axitinib each patient should receive based on the side effects they experience.
Primary objective To determine whether axitinib given on an individualized dose/schedule for metastatic renal cell carcinoma following immunotherapy with PD-1 and PD-L1 Inhibitors leads to improved progression-free survival (PFS). Secondary objectives: 1. To characterize the objective response rates in patients given axitinib on an individualized dose/schedule. 2. To evaluate the tolerability and safety of an alternative method of axitinib titration. 3. To characterize the anti-tumor effect, as measured by change in tumor burden per RECIST 1.1, of axitinib titration performed after initial RECIST PD on axitinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Median Progression-free Survival
The primary endpoint of progression-free survival in months (per per RECIST v1.1 criteria) will be estimated using the Kaplan-Meier method. Summary statistics will be provided along with 95% confidence intervals.
Time frame: Up to 18 months
Patients With Complete Response
Tumor Response, defined as overall confirmed objective response, is confirmed complete response (CR) according to the RECIST 1.1 criteria. RECIST 1.1: Complete response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Time frame: Up to 4 months of treatment and approximately 1 year of follow-up
Patients With Partial Response
Tumor Response, defined as overall confirmed objective response, is confirmed complete response (CR) according to the RECIST 1.1 criteria. RECIST 1.1: Partial response (PR) is defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: Up to 4 months of treatment and approximately 1 year of follow-up
Objective Response Rate (ORR)
ORR as defined by Recist V. 1.1. ORR = (CR + PR)
Time frame: Up to 4 months of treatment and approximately 1 year of follow-up
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