Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
NCT02811861 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,069 participants |
| Start Date | 2016-10-13 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02811861
The ClinicalTrials.gov registry entry for NCT02811861 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,069 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02811861 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Illinois, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02811861?
The interventions under investigation include: Pembrolizumab (DRUG), Everolimus (DRUG), Sunitinib (DRUG), Lenvatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02811861?
This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.