Lenvatinib and Pembrolizumab Simultaneous Combination Study

NCT03609359 | Completed Phase 2 Results

• 1 other identifier: EPOC 1706 study
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Gastric Cancer

Keywords

lenvatinib, pembrolizumab, phase II, gastric cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR will be defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR) for best overall response (confirmation required) according to immune-related RECIST (irRECIST) and RECIST v1.1.

  12 months

Secondary Outcomes (5)

• Number of Participants With Adverse Events (AEs)

  Basically 2 years, maximum 28 months

• Objective Response Rate (irORR)

  12 months

• Progression-free Survival (PFS)

  12 months

• Overall Survival (OS)

  28 months

• Disease Control Rate (DCR)

  2 years

Study Arms (1)

Lenvatinib + Pembrolizumab

EXPERIMENTAL

Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.

Drug: Lenvatinib; Drug: Pembrolizumab

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.

Also known as: E7080

Lenvatinib + Pembrolizumab

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).

Lenvatinib + Pembrolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have histologically or cytologically confirmed advanced or recurrent gastric cancer.
• Patients at least 20 years of age on the day of providing consent.
• Patients have measurable disease as defined by RECIST 1.1 as determined by investigator.
• Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group.
• 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
• Creatinine ≤1.5-times the upper limit of normal
• International normalized ratio (INR) ≤ 1.5
• Urinary protein : It satisfies one of the following (if any of the inspection criteria are satisfied, other examination may not be carried out) (i) Urinary protein (test paper method) is 2+ or less (ii) Urine Protein Creatinine (UPC) ratio \<3.5 (iii) 24-hour urine protein was measured, urinary protein ≦ 3500 mg
• Patients who not received a blood transfusion within 7 days of registration.
• Patients have recovered adverse events associated with chemotherapy, radiation and surgical operation as pretreatment to Grade 1 or lower with CTCAE v4.0 excluding stable symptoms (eg alopecia, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia etc.).

You may not qualify if:

• 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.
• Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
• 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.
• 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.
• 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.
• Patients with symptomatic brain metastasis.
• 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
• 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
• 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).
• Patients with a history of a gastrointestinal perforation and /or gastrointestinal fistula within 6 months before enrollment.
• Patients with active hepatitis.
• Patients with a history of human immunodeficiency virus (HIV).
• Patients with active symptoms or signs of interstitial lung disease.
• Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
• Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy \<14 days before enrollment.

Sponsors & Collaborators

• National Cancer Center Hospital East: lead
• Merck Sharp & Dohme LLC: collaborator
• Eisai Co., Ltd.: collaborator

Study Sites (1)

NationalCCHE

Kashiwa, Tokyo, 2778577, Japan

Location

Related Publications (1)

• Kawazoe A, Fukuoka S, Nakamura Y, Kuboki Y, Wakabayashi M, Nomura S, Mikamoto Y, Shima H, Fujishiro N, Higuchi T, Sato A, Kuwata T, Shitara K. Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial. Lancet Oncol. 2020 Aug;21(8):1057-1065. doi: 10.1016/S1470-2045(20)30271-0. Epub 2020 Jun 23.

  PMID: 32589866 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

lenvatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Dr.Kohei Shitara
• Organization: National Cancer Center Hospital East

LenvaPembro_core@east.ncc.go.jp

(+81)-4-7133-1111

Study Officials

• Kohei Shitara, Dr

  National Cancer Center Hospital East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant chief physician of Gastrointestinal Oncology Division

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 1, 2018
• Study Start: October 3, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Locations

JP (1)