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Lenvatinib and Pembrolizumab Simultaneous Combination Study

NCT03609359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-04-16

Study results available
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Summary

The efficacy and safety of the use of pembrolizumab in combination with lenvatinib.

Conditions

  • Advanced Gastric Cancer

Interventions

DRUG

Lenvatinib

Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.

DRUG

Pembrolizumab

Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • National Cancer Center Hospital East

    lead OTHER

Principal Investigators

  • Kohei Shitara, Dr · National Cancer Center Hospital East

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Japan

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03609359 on ClinicalTrials.gov