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NCT02501096 · ClinicalTrials.gov registry record · Phase 1
A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors
A Phase 1 study of Tumors, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT02501096 is a Phase 1 study of Tumors that has completed, run by Eisai. The registered enrollment target is 357 participants, above the 181-participant average among 20 other Tumors trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT02501096, a Phase 1 study of Tumors, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Lenvatinib
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers - Aurora
- Rocky Mountain Cancer Centers - Boulder
- Rocky Mountain Cancer Centers - Colorado Springs
- Rocky Mountain Cancer Centers, Site #1 - Denver
- Rocky Mountain Cancer Centers, Site #2 - Denver
- Rocky Mountain Cancer Centers - Lakewood
- Rocky Mountain Cancer Centers - Littleton
- Rocky Mountain Cancer Centers - Lone Tree
- Rocky Mountain Cancer Centers - Longmont
- Rocky Mountain Cancer Centers - Parker
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers - Thornton
Arizona
- Arizona Oncology Associates - Oro Valley
- Arizona Oncology Associates, PC - HOPE, Site #1 - Tucson
- Arizona Oncology Associates, PC - HOPE, Site #2 - Tucson
- Arizona Oncology Associates, PC - HOPE, Site #3 - Tucson
Florida
- Baptist Health Medical Group Oncology, LLC, Site #1 - Miami
- Baptist Health Medical Group Oncology, LLC, Site #2 - Miami
- Baptist Health Medical Group Oncology, LLC, Site #3 - Miami
Alaska
- Alaska Clinical Research Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2015-07-22 |
| Est. Completion | 2022-07-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02501096
The ClinicalTrials.gov registry entry for NCT02501096 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 20 other Tumors trials with a reported enrollment target (97% higher). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tumors appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02501096 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT02501096 about?
NCT02501096 is a clinical study titled "A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors". 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 \[Q3W\]) pembroli...
What is the current status of trial NCT02501096?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 357 participants. The study started on 2015-07-22. Estimated completion is 2022-07-11.
What conditions does trial NCT02501096 study?
This clinical trial studies the following conditions: Tumors.
What interventions are being tested in trial NCT02501096?
The interventions under investigation include: Pembrolizumab (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT02501096?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02501096 being conducted?
This trial has 20 study locations across Alaska, Arizona, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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