Lenvatinib and Pembrolizumab Simultaneous Combination Study

Sponsor
National Cancer Center Hospital East
Study ID
NCT03609359
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    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.
  • Pembrolizumab — DRUG
    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).

Study Details

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

Key Dates

Start date
Oct 3, 2018
Status verified
Mar 2025
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib + Pembrolizumab
    Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 12 months ]

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