CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
E7386 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05091346
NCT05091346Phase 2Completed

An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors

Eisai Inc.·interventional·Posted Oct 25, 2021·Updated Oct 24, 2025

In Brief

A Phase 2 clinical trial evaluating E7386, Pembrolizumab, and 1 other intervention for Melanoma and 2 related conditions. Completed, enrolled 89 participants across 32 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, Spain, United Kingdom, United States

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 25, 2021
Enrollment StartOct 27, 2021
Primary CompletionOct 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.7 years ago

Interventions

E7386drug

E7386 tablet.

Pembrolizumabdrug

Pembrolizumab IV infusion.

Lenvatinibdrug

Lenvatinib capsule.