Eisai Clinical Trials

Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors

E7080-A001-111

Study Overview

E7080
lenvatinib
NCT02501096, 2017-000300-26
Jul 2015 - Jul 2022
Solid Tumors

1. Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib [Time Frame: Cycle 1 (21 days)]

2. Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib [Time Frame: Cycle 1 (21 days)]

3. Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 [Time Frame: Week 24]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Completed

  • Phase 1 / 2

  • Norway, Spain, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Lee CH, Shah AY, Rasco D, Rao A, Taylor MH, Di Simone C, Hsieh JJ, Pinto A, Shaffer DR, Girones Sarrio R, Cohn AL, Vogelzang NJ, Bilen MA, Gunnestad Ribe S, Goksel M, Tennoe OK, Richards D, Sweis RF, Courtright J, Heinrich D, Jain S, Wu J, Schmidt EV, Perini RF, Kubiak P, Okpara CE, Smith AD, Motzer RJ. Lenvatinib plus pembrolizumab in patients with either treatment-naive or previously treated metastatic renal cell carcinoma (Study 111/KEYNOTE-146): a phase 1b/2 study. Lancet Oncol. 2021 Jul;22(7):946-958. doi: 10.1016/S1470-2045(21)00241-2. Epub 2021 Jun 15.

Data Sharing

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CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR