Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Melanoma and Colorectal Neoplasms, sponsored by Eisai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 based on investigator assessment. DLT was defined as any of the hematological or non-hematological toxicities events that: - Failure to administer greater than or equal to (\>=) 75 percentage (%) of the planned dosage of E7386 as a result of treatment-related toxicity; - Any treatment-related toxicity that causes the participant to discontinue treatment, even if the toxicity does
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 |
What the finished NCT05091346 record still lists
NCT05091346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05091346's enrollment target sits among peer trials
89 120th of 266 higher than 146 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
RECRUITING · Phase 1
-
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
RECRUITING · Phase 1
-
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
RECRUITING · Phase 1
-
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03682289 · 89 participants · Phase 2
Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors
- NCT04787939 · 89 participants · NA
Early Feeding After Oral Cavity Reconstruction
- NCT05480449 · 89 participants · Phase 1
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
- NCT05604131 · 89 participants · Phase 2
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI