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NCT05091346 · ClinicalTrials.gov registry record · Phase 1
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
A Phase 1 study of Melanoma and Colorectal Neoplasms, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
- 20
- Study locations
NCT05091346 is a Phase 1 study of Melanoma and Colorectal Neoplasms that has completed, run by Eisai. The registered enrollment target is 89 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT05091346, a Phase 1 study of Melanoma and Colorectal Neoplasms, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Lenvatinib
- DRUG E7386
Study Locations (20)
Other
- Chiba University Hospital - Chiba
- National Cancer Center Hospital - Chūōku
- Kurume University Hospital - Fukuoka
- National Cancer Center Hospital East - Kashiwa
- Osaka Metropolitan University Hospital - Osaka
- Kindai University Hospital - Ōsaka-sayama
- Sapporo-Kosei General Hospital - Sapporo
- Shizuoka Cancer Center Hospital - Shizouka
- Toranomon Hospital - Tokyo
California
- University of California, Los Angeles - Los Angeles
- University of California, Irvine Health - Orange
Florida
- Florida Cancer Specialists - Fort Myers
- SCRI Florida Cancer Specialists East - West Palm Beach
Georgia
- Winship Cancer Institute - Atlanta
Michigan
- Barbara Ann Karmanos Cancer Center - Detroit
New Jersey
- Rutgers cancer Institute of NJ - New Brunswick
New York
- Icahn School of Medicine at Mount Sinai - New York
Oregon
- Providence Medical Center Institute Franz Clinic - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2024-10-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05091346
The ClinicalTrials.gov registry entry for NCT05091346 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05091346 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05091346 about?
NCT05091346 is a clinical study titled "A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors". The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 p...
What is the current status of trial NCT05091346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2021-10-27. Estimated completion is 2024-10-15.
What conditions does trial NCT05091346 study?
This clinical trial studies the following conditions: Melanoma, Colorectal Neoplasms, Carcinoma, Hepatocellular.
What interventions are being tested in trial NCT05091346?
The interventions under investigation include: Pembrolizumab (DRUG), Lenvatinib (DRUG), E7386 (DRUG).
Who is sponsoring clinical trial NCT05091346?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05091346 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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