Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04246177
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) via oral capsules once a day during each 21-day cycle.
  • Pembrolizumab — BIOLOGICAL
    Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
  • Oral Placebo — DRUG
    Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
  • IV Placebo — DRUG
    Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
  • TACE — PROCEDURE
    Conducted as a background procedure of chemotherapeutic and embolic agent(s).

Study Details

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

Key Dates

Start date
May 22, 2020
Status verified
May 2026
Primary completion
Aug 19, 2025
Completion
Mar 26, 2026

Study Design

Enrollment
479 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib plus Pembrolizumab plus TACE
    Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
  • Active Comparator: Oral Placebo plus IV Placebo plus TACE
    Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Primary Outcome Measure

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to ~43 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates PC- HOPE ( Site 0770)TucsonArizona85711-
Scripps Clinic Torrey Pines ( Site 0714)La JollaCalifornia92037-
UCLA Hematology/Oncology - Santa Monica ( Site 0720)Los AngelesCalifornia90404-
USC Norris Comprehensive Cancer Center ( Site 0717)Los AngelesCalifornia90033-
UC Irvine Health ( Site 0718)OrangeCalifornia92868-
Yale Cancer Center ( Site 0724)New HavenConnecticut06510-
Tampa General Hospital ( Site 0764)TampaFlorida33606-
Mountain States Tumor Institute ( Site 0773)BoiseIdaho83712-
University of Iowa Hospital and Clinics ( Site 0729)Iowa CityIowa52242-
University of Kansas Cancer Center ( Site 0731)WestwoodKansas66205-
University of Louisville ( Site 0757)LouisvilleKentucky40202-
Tulane Medical Center ( Site 0787)New OrleansLouisiana70112-
University Medical Center New Orleans ( Site 0733)New OrleansLouisiana70112-
Henry Ford Hospital-GI/Hepatology Research ( Site 0735)DetroitMichigan48202-
Saint Louis University ( Site 0769)St LouisMissouri63110-
University of New Mexico Comprehensive Cancer Center ( Site 0805)AlbuquerqueNew Mexico87106-
Monter Cancer Center ( Site 0780)Lake SuccessNew York11042-
Icahn School of Medicine at Mount Sinai ( Site 0744)New YorkNew York10029-
Wake Forest Baptist Health ( Site 0741)Winston-SalemNorth Carolina27157-
University of Cincinnati Medical Center ( Site 0791)CincinnatiOhio45219-
The Ohio State University Wexner Medical Center ( Site 0759)ColumbusOhio43210-
ProMedica Flower Hospital ( Site 0796)SylvaniaOhio43560-
Stephenson Cancer Center ( Site 0745)Oklahoma CityOklahoma73104-
OHSU Center for Health & Healing ( Site 0746)PortlandOregon97239-
Penn State Hershey Medical Center ( Site 0766)HersheyPennsylvania17033-0850-
Houston Methodist Research Institute ( Site 0784)HoustonTexas77030-
Edwards Comprehensive Cancer Center ( Site 0786)HuntingtonWest Virginia25701-

Related coverage on Hipa.ai

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By research site
Arizona Oncology Associates PC- HOPE· Tucson, AZScripps Clinic Torrey Pines· La Jolla, CAUCLA Hematology/Oncology - Santa Monica· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health· Orange, CAYale Cancer Center· New Haven, CT

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