Trial · 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)
NCT03713593, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03713593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03713593
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT03713593
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 794 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- lenvatinib, pembrolizumab, saline placebo
- First posted
- 2018-10-22
- Last updated
- 2026-02-05
- Other registries' IDs
- eudract:2018-002983-26
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | PFS was defined as the time from the date of the first documentation of disease progression, as determined by blinded independent central review (BICR) per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. |
| Primary | Overall Survival (OS) | Up to approximately 41 months | OS was defined as the time from randomization until death from any cause |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. |
| Secondary | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | DOR was determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per RECIST 1.1 as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurred first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. |
| Secondary | Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | DCR was defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR. SD must be achieved at ≥6 weeks after randomization to be considered best overall response. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. |
| Secondary | Time to Disease Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed. |
| Secondary | Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per mRECIST by BICR or death due to any cause, whichever occurred first. mRECIST for HCC allowed evaluation of treatment effects that were not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the sum of diameters (SODs) of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. |
| Secondary | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | ORR wass defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable \[enhancement in the arterial phase\] target lesions, taking as reference the baseline sum of the diameters of target lesions) per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed. |
| Secondary | Duration of Response (DOR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | DOR was determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per mRECIST as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurs first. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed. |
| Secondary | Disease Control Rate (DCR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | DCR was defined as the percentage of participants who have a best overall response of CR, PR, or SD per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. SD must be achieved at ≥6 weeks after randomization to be considered best overall response. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed based on the population of responders (participants that achieved complete or partial response). | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Time to Disease Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | The analysis population consisted of all participants who received at least 1 dose of study treatment. Participants were analyzed based on the population of responders (participants that achieved complete or partial response). | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 41 months | The analysis population consisted of all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Pembrolizumab | 8.2 | 95% Confidence Interval 6.3 to 8.3 | Months | |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Placebo | 8.1 | 95% Confidence Interval 6.3 to 8.3 | Months | |
| Overall Survival (OS) | Lenvatinib + Pembrolizumab | 21.2 | 95% Confidence Interval 19.0 to 23.6 | Months | |
| Overall Survival (OS) | Lenvatinib + Placebo | 19.0 | 95% Confidence Interval 17.2 to 21.7 | Months | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Pembrolizumab | 26.1 | 95% Confidence Interval 21.8 to 30.7 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Placebo | 17.5 | 95% Confidence Interval 13.9 to 21.6 | Percentage of Participants | |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Pembrolizumab | 4.1 | Full Range 1.3 to 25.3 | Months | |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Placebo | 4.0 | Full Range 0.3 to 18.6 | Months | |
| Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Pembrolizumab | 81.3 | 95% Confidence Interval 77.1 to 85.0 | Percentage of Participants | |
| Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Lenvatinib + Placebo | 78.4 | 95% Confidence Interval 74.1 to 82.4 | Percentage of Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib + Pembrolizumab | 395 | |
| Overall Study | STARTED | Lenvatinib + Placebo | 399 | |
| Overall Study | COMPLETED | Lenvatinib + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Lenvatinib + Placebo | 0 | |
| Overall Study | NOT COMPLETED | Lenvatinib + Pembrolizumab | 395 | |
| Overall Study | NOT COMPLETED | Lenvatinib + Placebo | 399 |
Source ClinicalTrials.gov
Adverse events668
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab | 51 | 395 | 61 |
| other | Anaemia | Blood and lymphatic system disorders | Lenvatinib + Placebo | 64 | 395 | 88 |
| other | Neutropenia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab | 19 | 395 | 54 |
| other | Neutropenia | Blood and lymphatic system disorders | Lenvatinib + Placebo | 22 | 395 | 38 |
| other | Hyperthyroidism | Endocrine disorders | Lenvatinib + Pembrolizumab | 31 | 395 | 32 |
| other | Hyperthyroidism | Endocrine disorders | Lenvatinib + Placebo | 15 | 395 | 16 |
| other | Hypothyroidism | Endocrine disorders | Lenvatinib + Pembrolizumab | 167 | 395 | 207 |
| other | Hypothyroidism | Endocrine disorders | Lenvatinib + Placebo | 159 | 395 | 202 |
| other | Abdominal distension | Gastrointestinal disorders | Lenvatinib + Pembrolizumab | 27 | 395 | 33 |
| other | Abdominal distension | Gastrointestinal disorders | Lenvatinib + Placebo | 18 | 395 | 20 |
1 to 10 of 668Source ClinicalTrials.gov
See all 668 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib + Pembrolizumab | 314 | 395 |
| Total, all-cause mortality | Lenvatinib + Placebo | 352 | 399 |
| Total, other adverse events | Lenvatinib + Pembrolizumab | 390 | 395 |
| Total, other adverse events | Lenvatinib + Placebo | 388 | 395 |
| Total, serious adverse events | Lenvatinib + Pembrolizumab | 185 | 395 |
| Total, serious adverse events | Lenvatinib + Placebo | 159 | 395 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38039993 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: Number of Participants Who Experienced an Hepatic Event of Clinical Interest (HECI) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: Number of Participants Who Experienced an Immune-related Adverse Event (irAE) of Clinical Interest | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: Number of Participants Who Experienced an Serious Adverse Event (SAE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: deaths from any cause | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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