Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04246177 | 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) | PHASE3 | COMPLETED | 479 | — | — | May 22, 2020 | Mar 26, 2026 | May 14, 2026 | 205 | United States, Australia +25 |
| NCT03713593 | Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) | PHASE3 | COMPLETED | 794 | — | — | Dec 31, 2018 | Sep 24, 2024 | Feb 5, 2026 | 172 | United States, Australia +19 |
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).
OS is defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Lenvatinib plus Pembrolizumab plus TACE | EXPERIMENTAL | 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). |
| Oral Placebo plus IV Placebo plus TACE | ACTIVE_COMPARATOR | 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). |
| lenvatinib plus pembrolizumab | EXPERIMENTAL | Participants receive lenvatinib 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 (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity. |
| lenvatinib plus placebo | ACTIVE_COMPARATOR | Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| 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). |
| saline placebo | DRUG | Administered as an IV infusion on Day 1 Q3W |
Inclusion Criteria: * Has a diagnosis of HCC confirmed by radiology, histology, or cytology * Has HCC localized to the liver and not amenable to curative treatment * Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study interventi...