Loading clinical trials...

COMPLETEDPHASE2

Lenvatinib and Pembrolizumab Simultaneous Combination Study

An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in Patients With Advanced Gastric Cancer

NCT03609359•National Cancer Center Hospital East

View on ClinicalTrials.gov

Summary

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

Detailed Description

In this study, if combination therapy with lenvatinib and pembrolizumab in patients with gastric cancer is judged to be effective, a prospective treatment regimen can be expected for a larger number of participating subjects. The anticipated disadvantages include any adverse events associated with lenvatinib and pembrolizumab. To minimize the risk and disadvantages of adverse events, the data center together with the Data and Safety Monitoring Committee will monitor any adverse events in the present trial to determine whether or not they are within the expected range. These bodies will also conduct a thorough examination in the event that serious or unexpected adverse events occur, and adopt an appropriate system to take any necessary actions.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients have histologically or cytologically confirmed advanced or recurrent gastric cancer.
•2. Patients at least 20 years of age on the day of providing consent.
•3. Patients have measurable disease as defined by RECIST 1.1 as determined by investigator.
•4. Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group.
•5. Patients with adequate organ function at the time of enrollment as defined below:
•* Neutrophil count ≥1200mm3
•* Platelet count ≥7.5 × 104/mm3
•* Hemoglobin (Hb) ≥ 8.0 g/dL,
•* Total bilirubin ≤1.5 mg/dL
•* Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 100 IU/L for subjects with liver metastases ≤ 200 IU/L
+8 more criteria

Exclusion Criteria

•1. Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs.
•2. Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
•3. Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1, anti-programmed ligand death 1, or anti-programmed ligand death 2.
•4. Patients with hypertension that is difficult to control (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents.
•5. Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment.
•6. Patients with symptomatic brain metastasis.
•7. Patients with a history of New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months
•8. Patients have an active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months
•9. Patients have severe (hospitalization required) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, mental disease, cerebrovascular disease etc).
•10. Patients with a history of a gastrointestinal perforation and /or gastrointestinal fistula within 6 months before enrollment.
+11 more criteria

Locations (1)

NationalCCHE

Kashiwa, Tokyo, Japan

Key Dates

Start Date

October 3, 2018

Primary Completion Date

April 30, 2021

Completion Date

April 30, 2021

Last Updated

April 16, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Gastric Cancer

Interventions

Lenvatinib

DRUG

Pembrolizumab

DRUG

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

NCT07259226

Advanced Breast CancerAdvanced Gastric Cancer+2 more

View study

RECRUITINGPHASE2

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

NCT07102901

Advanced Gastric CancerMetastatic Gastric Cancer+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lenvatinib and Pembrolizumab Simultaneous Combination Study

Inclusion Criteria

Exclusion Criteria

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer

SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen

Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial