This is a single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus in participants with unresectable advanced or metastatic non clear cell renal cell carcinoma (nccRCC) who have not received any chemotherapy for advanced disease. The primary objective of the study is to evaluate the objective response rate (ORR). This study consists of three phases: a Pretreatment Phase (Screening and Baseline Periods), a Treatment Phase (starting Cycle 1, Day 1), and a Posttreatment Phase (End of Treatment Visit and survival Follow-up).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
4 mg and 10 mg capsules
5 mg tablets
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Texas Oncology
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Objective Response Rate (ORR)
ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (up to approximately 3 years 9 months)
Progression-free Survival (PFS)
PFS was assessed by investigator per RECIST v1.1, defined as time from date of first dose of study drug to date of first documentation of progressive disease (PD) or death whichever occurred first. PD: greater than or equal to (\>=) 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of \>=5 mm. Appearance of \>=1 new lesions also considered PD. PFS was analyzed using Kaplan Meier method. PFS was censored on date of last adequate radiologic assessment prior to new anticancer therapy, more than one missed visits, treatment discontinuation, and cutoff date when no PD or death occurred before any of these (on first dose of study treatment if no adequate post baseline tumor assessment was available), per publication by Food and Drug Administration (FDA) 'Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (2007).
Time frame: From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (up to approximately 3 years 9 months)
Overall Survival (OS)
OS was defined as the time from the date of the first dose of study drug until the date of death from any cause. OS was analyzed using Kaplan Meier method. In the absence of death before data cutoff, participants were censored either at the date last known to be alive or the date of data cutoff, whichever came earlier. Participants were followed for survival every 12 weeks after the end of treatment visit. If a clinic visit was not feasible, follow-up information was obtained via telephone or email.
Time frame: From the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
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