CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
lenvatinib +1 moredrug
Likely dose
lenvatinib 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02915783
NCT02915783Phase 2Completed
CompareCT.gov

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

Eisai Inc.·interventional·Posted Sep 27, 2016·Updated Jan 17, 2023

In Brief

A Phase 2 clinical trial evaluating lenvatinib and everolimus for Non Clear Cell Renal Cell Carcinoma (nccRCC). Completed, enrolled 41 participants across 8 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Clear Cell Renal Cell Carcinoma (nccRCC)
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 27, 2016
Enrollment StartFeb 20, 2017
Primary CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.8 years ago

Interventions

lenvatinibdrug

4 mg and 10 mg capsules

everolimusdrug

5 mg tablets