At a glance
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An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors
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
Timeline
Interventions
E7386 tablet.
Pembrolizumab IV infusion.
Lenvatinib capsule.