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Advanced Gastric CancerPhase 2Lenva+PembroNCT03609359

Lenvatinib and Pembrolizumab Simultaneous Combination Study

A Phase 2 study testing Lenvatinib and Pembrolizumab in people with Advanced Gastric Cancer, run by National Cancer Center Hospital East at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The efficacy and safety of the use of pembrolizumab in combination with lenvatinib. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Lenvatinib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteJapan
Study dates
3 Oct 2018to 30 Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.).
  • Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.
  • Patients capable of taking oral medication
  • Patients who provided written informed consent to be subjects in this trial

Who cannot join

  • 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.
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  • 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.
  • Patients have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
  • Patients who are administered live vaccines <30 days before the initiation of treatment with the investigational drug.
  • Patients have serious non-healing wound, ulcer, or bone fracture.
  • Females who are pregnant or breastfeeding
  • Patients have no intention to comply with the protocol or cannot comply.
  • Patients were judged unsuitable as subject of this trial by investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • NationalCCHE

    Kashiwa, Tokyo, 2778577

Other trials in Japan

About this study

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

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

Read the 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.

Keywords
lenvatinib, pembrolizumab, phase II, gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080

    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.

  • PembrolizumabDrug

    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 groups in NCT03609359
Study groupRoleWhat they receive
Lenvatinib + PembrolizumabExperimentalLenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Receives: Drug: Lenvatinib; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (5)

  1. Number of Participants With Adverse Events (AEs)

    • Number of each AE of the worst grade occurring in this study was evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and tabulated throughout all cycles. This study also includes a special note regarding abnormal laboratory values. When clinical signs and symptoms observed in this study were elicited, diagnosis and related data were collected based on whether they were due to abnormal laboratory values. Therefore, for example, grading results for liver dysfunction may differ between non-hematologic toxicities and laboratory values.
    • Adverse-Events occurrences means "prevalence proportion" of any undesirable occurrence based on investigator's medical decision in this study.

    Measured: Basically 2 years, maximum 28 months

  2. Objective Response Rate (irORR)

    Objective response rate (irORR) according to immune-related (ir) RECIST

    Measured: 12 months

  3. Progression-free Survival (PFS)

    • 1 "Progression" will be PD based on diagnostic imaging according to overall response by RECIST v1.1. The day of the imaging test will be defined as the day of progression. When the treatment are discontinued due to clinical PD and diagnostic imaging can't be performed, the day of clinical PD will be defined as the day of progression.
    • 2 Surviving patients, who are not assessed as progression will be censored on the last day when no progression is confirmed on imaging (last day of PFS confirmed)
    • 3 For patients who died without being assessed as progression, whether to consider to be an "event on the day of death" or "censoring on the last day of PFS confirmed" should be decided at the time of data review performed prior to data fixation. In principle, they should be "an "event on the day of death" unless the period from the last day of PFS confirmed to the day of death is long.

    Measured: 12 months

  4. Overall Survival (OS)

    • The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause. Surviving patients should be censored on the last day of PFS confirmed. Patients who are lost to follow up should be censored on the last day when their survival is confirmed before being lost to follow up.
    • The protocol for this clinical trial stipulated that the observation period was "2 years from the date of registration of the last case." Meanwhile, OS was stipulated as "the period from the date of registration to the date of death from any cause. For surviving cases, the period was censored at the date of last confirmed survival." The observation period varied by case, with follow-up surveys lasting up to 28 months.

    Measured: 28 months

  5. Disease Control Rate (DCR)

    The DCR will be defined as the percentage of patients who achieved CR or PR, or Stable Disease (SD) for best overall response according to RECIST v1.1.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start3 Oct 2018
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609359
Sponsor's protocol ID
EPOC 1706 study
Acronym
Lenva+Pembro
Status last verified
Mar 2025
First submitted
23 Jul 2018
Last updated
16 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32589866

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib and Pembrolizumab in people with Advanced Gastric Cancer, run by National Cancer Center Hospital East at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03609359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

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