Trial · NCT03797326
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
NCT03797326, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2025-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005). Trials, record NCT03797326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03797326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
- NCT number
- NCT03797326
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 611 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, Glioblastoma, Biliary Tract Cancers, Pancreatic Cancer
- Interventions
- Pembrolizumab, Lenvatinib
- First posted
- 2019-01-09
- Last updated
- 2026-05-04
- Other registries' IDs
- eudract:2018-003747-37
- Results first posted
- 2025-11-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment | Up to approximately 66 months | ORR was defined as the percentage of participants who had a best overall response of either 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 as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint. |
| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR) | Up to approximately 66 months | ORR was defined as the percentage of participants who had a best overall response of either 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 as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint. |
| Primary | Number of Participants With One or More Adverse Events (AEs) | Up to approximately 66 months | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented. |
| Primary | Number of Participants Who Discontinued From Study Treatment Due to an AE | Up to approximately 62 months | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented. |
| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment | Up to approximately 66 months | DCR was defined per RECIST 1.1 as the percentage of participants who have a 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) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint. |
| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Up to approximately 66 months | DCR was defined per RECIST 1.1 as the percentage of participants who have a 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) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment | Up to approximately 66 months | For participants who demonstrate 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) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Up to approximately 66 months | For participants who demonstrate 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) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation. |
| Secondary | Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment | Up to approximately 66 months | PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint. |
| Secondary | Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Up to approximately 66 months | PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. | Months | MEDIAN |
| SECONDARY | Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days. | All allocated participants who received at least 1 dose of study intervention and had data available for this endpoint. | ng*hr/mL | MEAN |
| PRIMARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| PRIMARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR) | Up to approximately 66 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 51.6 | 95% Confidence Interval 33.1 to 69.8 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment | Cohort B: Ovarian Cancer (Lenva + Pembro) | 77.4 | 95% Confidence Interval 58.9 to 90.4 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Cohort C: Gastric Cancer (Lenva + Pembro) | 53.5 | 95% Confidence Interval 43.2 to 63.6 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Cohort D1: Colorectal Cancer (Lenva + Pembro) | 52.4 | 95% Confidence Interval 42.4 to 62.2 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Cohort D2: Colorectal Cancer (Lenva) | 56.7 | 95% Confidence Interval 37.4 to 74.5 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 57.4 | 95% Confidence Interval 47.2 to 67.2 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 64.7 | 95% Confidence Interval 54.6 to 73.9 | Percentage of Participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR | Cohort G: Pancreatic Cancer (Lenva + Pembro) | 37.9 | 95% Confidence Interval 28.5 to 48.0 | Percentage of Participants | |
| Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 22.9 | 95% Confidence Interval 4.2 to NA | Months | |
| Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment | Cohort B: Ovarian Cancer (Lenva + Pembro) | 15.3 | 95% Confidence Interval 6.4 to NA | Months |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 31 | |
| Overall Study | STARTED | Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 | |
| Overall Study | STARTED | Cohort C: Gastric Cancer (Lenva + Pembro) | 102 | |
| Overall Study | STARTED | Cohort D1: Colorectal Cancer (Lenva + Pembro) | 107 | |
| Overall Study | STARTED | Cohort D2: Colorectal Cancer (Lenva) | 32 | |
| Overall Study | STARTED | Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 102 | |
| Overall Study | STARTED | Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 103 | |
| Overall Study | STARTED | Cohort G: Pancreatic Cancer (Lenva + Pembro) | 103 | |
| Overall Study | Treated | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 31 | |
| Overall Study | Treated | Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events2,640
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 | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 5 | 31 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Ovarian Cancer (Lenva + Pembro) | 4 | 31 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort C: Gastric Cancer (Lenva + Pembro) | 17 | 99 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort D1: Colorectal Cancer (Lenva + Pembro) | 12 | 105 | 19 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort D2: Colorectal Cancer (Lenva) | 6 | 30 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 3 | 101 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 11 | 102 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort G: Pancreatic Cancer (Lenva + Pembro) | 15 | 103 | 17 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 0 | 31 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort B: Ovarian Cancer (Lenva + Pembro) | 0 | 31 | 0 |
1 to 10 of 2,640Source ClinicalTrials.gov
See all 2,640 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 27 | 31 |
| Total, all-cause mortality | Cohort B: Ovarian Cancer (Lenva + Pembro) | 28 | 31 |
| Total, all-cause mortality | Cohort C: Gastric Cancer (Lenva + Pembro) | 97 | 102 |
| Total, all-cause mortality | Cohort D1: Colorectal Cancer (Lenva + Pembro) | 97 | 107 |
| Total, all-cause mortality | Cohort D2: Colorectal Cancer (Lenva) | 30 | 32 |
| Total, all-cause mortality | Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 99 | 102 |
| Total, all-cause mortality | Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 98 | 103 |
| Total, all-cause mortality | Cohort G: Pancreatic Cancer (Lenva + Pembro) | 101 | 103 |
| Total, other adverse events | Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 30 | 31 |
| Total, other adverse events | Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 | 31 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT03797326
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