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NCT02811861 · ClinicalTrials.gov registry record · Phase 3

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

A Phase 3 study of Renal Cell Carcinoma, sponsored by Eisai.

Active
Registry status
Phase 3
Development phase
1,069
Enrollment target
20
Study locations

NCT02811861: Active Phase 3 study of Renal Cell Carcinoma, sponsored by Eisai.

NCT02811861 is a Phase 3 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Eisai. The registered enrollment target is 1,069 participants, above the 234-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (357% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02811861, a Phase 3 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Eisai.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,069 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

Primary Outcome

PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS

Conditions Studied

Renal Cell Carcinoma

Interventions

  • DRUG Pembrolizumab
  • DRUG Everolimus
  • DRUG Sunitinib
  • DRUG Lenvatinib

Study Locations (20)

Florida

  • Boca Raton Community Hospital - Boca Raton
  • Florida Cancer Specialists - Fort Myers
  • University of Miami - Miami
  • Mount Sinai Medical Center - Miami Beach
  • Florida Hospital Cancer Institute - Orlando
  • Florida Cancer Specialists ( North Region) - St. Petersburg
  • Florida Cancer Specialists - West Palm Beach

Illinois

  • Joliet Oncology - Hematology Associates - Joliet
  • Healthcare Research Network III, LLC - Tinley Park

Kansas

  • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Overland Park
  • Cotton-Oneil Clinical Research Center - Topeka

Massachusetts

  • Massachusetts General Hospital- MGH - Boston
  • Dana Farber Cancer Institute - Boston

Nebraska

  • GU Research Network - Omaha
  • Nebraska Cancer Specialists - Omaha

California

  • Stanford School of Medicine - Stanford

Louisiana

  • Ochsner Clinic Foundation - New Orleans

Maryland

  • Associates in Oncology & Hematology, PC - Bethesda

Trial Details

FieldValue
Enrollment Target 1,069 participants
Start Date 2016-10-13
Est. Completion 2027-03-31
Phase Phase 3
Eisai

287 total trials

What the registry record for NCT02811861 still lists

NCT02811861 is an interventional study that assigns participants to a tested intervention. Its 1,069 participants enrollment target places it among the larger protocols in the corpus, above the 234-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (357% higher).

The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT02811861 names 20 study sites across 10 states, led by Florida, Illinois, Kansas.

Frequently Asked Questions

What is clinical trial NCT02811861 about?

NCT02811861 is a clinical study titled "Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma". The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in...

What is the current status of trial NCT02811861?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,069 participants. The study started on 2016-10-13. Estimated completion is 2027-03-31.

What conditions does trial NCT02811861 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma.

What interventions are being tested in trial NCT02811861?

The interventions under investigation include: Pembrolizumab (DRUG), Everolimus (DRUG), Sunitinib (DRUG), Lenvatinib (DRUG).

Who is sponsoring clinical trial NCT02811861?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02811861 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02811861's enrollment target sits among peer trials

1,069 4th of 121 higher than 118 of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02811861, the US trial registry maintained by the National Library of Medicine. NCT02811861 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.