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Completed Phase 1Phase 2 Interventional Results available

A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

ClinicalTrials.gov ID: NCT02501096

Public ClinicalTrials.gov record NCT02501096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 4:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous \[IV\], every 3 weeks \[Q3W\]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, melanoma or leiomyosarcoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 7 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).

Study identification

NCT ID
NCT02501096
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Eisai Inc.
Industry
Enrollment
357 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 21, 2015
Primary completion
Aug 17, 2020
Completion
Jul 10, 2022
Last update posted
Jul 19, 2023

2015 – 2022

United States locations

U.S. sites
50
U.S. states
13
U.S. cities
37
Facility City State ZIP Site status
Alaska Clinical Research Center Anchorage Alaska — —
Arizona Oncology Associates Oro Valley Arizona — —
Arizona Oncology Associates, PC - HOPE, Site #1 Tucson Arizona — —
Arizona Oncology Associates, PC - HOPE, Site #2 Tucson Arizona — —
Arizona Oncology Associates, PC - HOPE, Site #3 Tucson Arizona — —
Rocky Mountain Cancer Centers Aurora Colorado — —
Rocky Mountain Cancer Centers Boulder Colorado — —
Rocky Mountain Cancer Centers Colorado Springs Colorado — —
Rocky Mountain Cancer Centers, Site #1 Denver Colorado — —
Rocky Mountain Cancer Centers, Site #2 Denver Colorado — —
Rocky Mountain Cancer Centers Lakewood Colorado — —
Rocky Mountain Cancer Centers Littleton Colorado — —
Rocky Mountain Cancer Centers Lone Tree Colorado — —
Rocky Mountain Cancer Centers Longmont Colorado — —
Rocky Mountain Cancer Centers Parker Colorado — —
Rocky Mountain Cancer Centers Pueblo Colorado — —
Rocky Mountain Cancer Centers Thornton Colorado — —
Baptist Health Medical Group Oncology, LLC, Site #1 Miami Florida — —
Baptist Health Medical Group Oncology, LLC, Site #2 Miami Florida — —
Baptist Health Medical Group Oncology, LLC, Site #3 Miami Florida — —
Boca Raton Clinical Research Medical Center Plantation Florida — —
Piedmont Cancer Institue Atlanta Georgia — —
The University of Chicago Chicago Illinois — —
Beth Israel Deaconess Medical Center Boston Massachusetts — —
Mass General Hospital Boston Massachusetts — —
University of Minnesota, Masonic Cancer Center Minneapolis Minnesota — —
Comprehensive Cancer Centers of Nevada, Site #1 Henderson Nevada — —
Comprehensive Cancer Centers of Nevada, Site #2 Henderson Nevada — —
Comprehensive Cancer Centers of Nevada, Site #3 Henderson Nevada — —
Comprehensive Cancer Centers of Nevada, Site #1 Las Vegas Nevada — —
Comprehensive Cancer Centers of Nevada, Site #2 Las Vegas Nevada — —
Comprehensive Cancer Centers of Nevada, Site #3 Las Vegas Nevada — —
Comprehensive Cancer Centers of Nevada, Site #4 Las Vegas Nevada — —
New York Hematology Oncology (US Onc) Albany New York — —
Memorial Sloan Kettering at Westchester Harrison New York — —
Memorial Sloan Kettering Cancer Center New York New York — —
Oregon Health & Science University Portland Oregon — —
University of Pennsylvania Philadelphia Pennsylvania — —
Texas Oncology-Bedford Bedford Texas — —
Texas Oncology (US Onc) Dallas Texas — —
Texas Oncology Dallas Texas — —
Texas Oncology-Denton South Denton Texas — —
Texas Oncology-Fort Worth, Site #1 Fort Worth Texas — —
Texas Oncology-Grapevine Grapevine Texas — —
Texas Oncology-Longview Cancer Center Longview Texas — —
Texas Oncology-Plano West Plano Texas — —
South Texas Accelerated Research Therapeutics, LLC San Antonio Texas — —
Texas Oncology-Tyler Tyler Texas — —
Texas Oncology-Waco, Site #1 Waco Texas — —
Texas Oncology-Waco, Site #2 Waco Texas — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02501096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 19, 2023 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02501096 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →