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COMPLETED Phase 1

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

NCT05091346 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 89 participants
Start Date 2021-10-27
Est. Completion 2024-10-15
Phase Phase 1

Sponsor

Eisai

71 total trials

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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. It is categorized as Phase 1, 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 89 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 3 conditions, with Melanoma appearing as the primary indexed condition, and to 3 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: NCT05091346 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05091346?

The interventions under investigation include: Pembrolizumab (DRUG), Lenvatinib (DRUG), E7386 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05091346?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial