臨床研究等提出・公開システム

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular Carcinoma

Tanaka Yoshiyuki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

JPCT@merck.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

JPCT@merck.com

completed

June. 22, 2020

Interventional

Multicenter, randomized, parallel-group, placebo-controlled in combination with TACE, Double-blind study

treatment purpose

3

1) Has a diagnosis of HCC confirmed by radiology, histology, or cytology
2) Has HCC localized to the liver and not amenable to curative treatment
3) Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
4) Participants with Hepatitis B virus (HBV) are eligible
5) Has adequately controlled blood pressure with or without antihypertensive medications
6) Has adequate organ function

1) Is currently a candidate for liver transplantation
2) Has had gastric bleeding within the last 6 months
3) Has ascites that is not controlled with medication
4) Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
5) Has a serious nonhealing wound, ulcer, or bone fracture
6) Has received locoregional therapy to existing liver lesions

Both

Hepatocellular Carcinoma

investigatipnal material(s)
Generic name etc: Pembrolizumab+Lenvatinib+TACE
INN of investigational material: Pembrolizumab,Lenvatinib
Therapeutic category code: 429 Other antitumor agents
Dosage and Administration for investigational material: Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W)+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 + TACE

Pembrolizumab, Lenvatinib: Participants who complete 2 years of treatment may continue to receive lenvatinib alone until progression or intolerable toxicity.

control material(s)
Generic name etc: placebo+TACE
INN of investigational material: -
Therapeutic category code: - other
Dosage and Administration for investigational material: IV Placebo Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W) + Oral Placebo Lenvatinib-matching placebo administered via oral capsules once a day+ TACE

placebo: Participants who complete 2 years of treatment may continue to receive oral placebo alone until progression or intolerable toxicity.

efficacy
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1): PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
- Overall Survival (OS): OS is defined as the time from randomization to death due to any cause.

efficacy
safety
- PFS, Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- Percentage of Participants Who Experience At Least One Adverse Event (AE), Serious Adverse Event (SAE), Hepatic Event of Clinical Interest (ECI)
- Percentage of Participants Who Discontinue Study Drug Due to an AE

May. 25, 2020