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Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma Treatment Study

Clinical Trial Title: 
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 nccRCC who have not received any chemotherapy for advanced disease.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Timothy Kuzel, MD
Clinical Trial Protocol Description: 

To provide lenvatinib in combination with everolimus in treatment for patients with advanced or metastatic non clear cell renal cell carcinoma (nccRCC) and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have histologically confirmed nccRCC and have not received any chemotherapy for advanced disease. Subjects must have one of the following subtypes of nccRCC:
    • Papillary
    • Chromophobe
    • Collecting duct carcinoma (CDC)
    • Renal medullary carcinoma (RMC)
    • Unclassified
  • Have radiologically measurable disease that meets the following criteria:
    • Have at least 1 lesion of ≥ 10 mm in the longest diameter for a nonlymph node or ≥ 15 mm in the short axis diameter for a lymph node which is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using computerized tomography (CT) or magnetic resonance imaging (MRI).
    • Have lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation and show evidence of subsequent progressive disease (substantial size increase of ≥20%) to be deemed a target lesion.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Have blood pressure (BP) ≤ 140/90 mmHg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to cycle 1/day 1.

You will be excluded from the study if any of the following criteria apply to you:

  • Have predominant clear cell renal cell carcinoma (RCC).
  • Have had prior anticancer chemotherapy or targeted therapy for advanced nccRCC.
  • Have had prior exposure to lenvatinib or mammalian target of rapamycin (mTOR) inhibitor.
  • Have a known intolerance to lenvatinib, everolimus (or other rapamycin derivatives), or any of the excipients.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Kidney and Urinary System Disorders
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC