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A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease

A Single-arm, Multicenter, Phase 2 Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease

NCT02915783•Eisai Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females age ≥18 years at the time of informed consent form (ICF)
•Participants with histologically confirmed non clear cell renal cell carcinoma (nccRCC) who have not received any chemotherapy for advanced disease. Participants must have one of the following subtypes of nccRCC: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
•Radiologically measurable disease meeting the following criteria:
•1. At least 1 lesion of ≥10 millimeters (mm) in the longest diameter for a nonlymph node or ≥15 mm in the short axis diameter for a lymph node that is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computerized tomography (CT) or magnetic resonance imaging (MRI);
•2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of subsequent progressive disease (substantial size increase of ≥20%) to be deemed a target lesion.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•Blood pressure (BP) ≤140/90 millimeters of mercury (mmHg) at Screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1.
•Adequate renal function as evidenced by calculated creatinine clearance ≥30 milliliters (mL)/minute according to the Cockcroft and Gault formula
•Adequate bone marrow function:
•1. Absolute neutrophil count (ANC) ≥1.5 × 10\^9/liter (L);
+6 more criteria

Exclusion Criteria

•Predominant clear cell renal cell carcinoma (RCC)
•Prior anticancer chemotherapy or targeted therapy for advanced nccRCC
•Prior exposure to lenvatinib or mammalian target of rapamycin (mTOR) inhibitor
•Known intolerance to lenvatinib, everolimus (or other rapamycin derivatives), or any of the excipients
•Major surgery performed within 3 weeks prior to the first dose of study drugs or scheduled for major surgery during the study
•Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib or everolimus
•Participants having \>1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 grams (g)/24 hours will be ineligible.
•Fasting total cholesterol ˃300 milligrams (mg)/dL (or ˃7.75 millimoles \[mmol\]/L) or fasting triglycerides level ˃2.5 × ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.
•Uncontrolled diabetes as defined by fasting glucose \>1.5 times the ULN. Note: In case this threshold is exceeded, these participants can only be included after initiation or adjustment of glucose-lowering medication.
•Known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.
+18 more criteria

Locations (8)

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

Key Dates

Start Date

February 20, 2017

Primary Completion Date

November 2, 2021

Completion Date

November 2, 2021

Last Updated

January 17, 2023

Enrollment

ACTUAL participants

Conditions

Non Clear Cell Renal Cell Carcinoma (nccRCC)

Interventions

lenvatinib

DRUG

everolimus

DRUG