Trial · NCT02501096
A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors
NCT02501096, Phase 1, Phase 2, Completed, Eisai Inc.; results first posted 2023-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors. Trials, record NCT02501096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02501096
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors
- NCT number
- NCT02501096
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 357 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Tumors
- Interventions
- Lenvatinib, Pembrolizumab
- First posted
- 2015-07-17
- Last updated
- 2023-07-20
- Other registries' IDs
- eudract:2017-000300-26
- Results first posted
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib | Cycle 1 (21 days) | MTD was confirmed if no more than 3 participants experience dose-limiting toxicities(DLTs)during first 3 weeks (Cycle 1) of treatment.If MTD was not confirmed at dose level,then enrollment was proceeded to next lower dose level.Sponsor and investigators reviewed all participants' safety;clinical data to jointly determine RP2D of combination of treatment.DLT may be any of following: hematological/nonhematological toxicities considered to be at least possibly related to Lenvatinib/pembrolizumab occurring during Cycle 1;Failure to administer greater than or equal to (\>=) 75 percent (%) of planned dosage of lenvatinib as result of treatment-related toxicity during Cycle 1;Who discontinue treatment due to treatment-related toxicity.Greater than 2 week delay in starting Cycle 2 because of treatment-related toxicity,even if toxicity does not meet DLT criteria.Toxicity was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03(NCI CTCAE v 4.03). |
| Primary | Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Cycle 1 (21 days) | A DLT was defined as any of the following: any of the hematological or nonhematological toxicities considered to be at least possibly related to lenvatinib and/or pembrolizumab occurring during Cycle 1. Failure to administer \>=75% of the planned dosage of lenvatinib as a result of treatment-related toxicity during Cycle 1. Participants who discontinue treatment due to treatment-related toxicity. Greater than 2 week delay in starting Cycle 2 because of a treatment-related toxicity, even if the toxicity does not meet DLT criteria. Toxicity was evaluated as per NCI CTCAE v 4.03. |
| Primary | Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 | Week 24 | ORR was defined as the percentage of participants whose best overall response (BOR) was immune related complete response (irCR) or immune related partial response (irPR) based on investigator assessment according to irRECIST version 1.1. irCR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). irPR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From date of first dose up to 30 days after the last dose of study drugs (Up to 74 months) | TEAE: adverse event (AE) emerged during treatment, having been absent at pretreatment or reemerged during treatment, present at pretreatment but stopped before treatment or worsened in severity during treatment relative to pretreatment state, when AE is continuous. AE: any untoward medical occurrence in participant administered an investigational product. TEAEs were based on participants laboratory tests, regular measurement of vital signs, echocardiograms/multigated acquisition scans to assess left ventricular ejection fraction and electrocardiograms parameter values. TESAE: any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; a congenital anomaly/birth defect or was medically important due to reasons other than above criteria. |
| Secondary | Objective Response Rate (ORR) Based on irRECIST Version 1.1 | From date of first dose of study drug administration until immune related (irPD), development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | ORR was defined as the percentage of participants whose BOR was irCR or irPR according to irRECIST version 1.1. irCR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. irPR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Progression-free Survival (PFS) Based on irRECIST Version 1.1 | From date of first dose of study drug administration to date of irPD or date of death, whichever occurred first (up to 73 months) | PFS was defined as the time from the first dose date to the date of irPD or date of death (whichever occurred first) according to irRECIST version 1.1. irPD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). |
| Secondary | Overall Survival (OS) | From the first dose until death from any cause, up to 73 months | OS was defined as the time from the first dose date to the date of death from any cause. |
| Secondary | Disease Control Rate (DCR) Based on irRECIST Version 1.1 | From first dose of the study drug until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | DCR: percentage of participants with a confirmed irCR, irPR, or ir-stable disease (SD) (duration of irSD greater than or equal to \[\>=\] 5 weeks). DCR was assessed on irRECIST v1.1. irCR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have reduction in their short axis to \<10 mm. irPR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference baseline sum of longest diameter. irSD: neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for irPD, taking as reference smallest sum diameters while on study. irPD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). |
| Secondary | Clinical Benefit Rate (CBR) Based on irRECIST Version 1.1 | From first dose date until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | CBR was defined as the percentage of participants with BOR of irCR or irPR or irdurable stable disease (irdSD) (duration of irSD \>=23 weeks) \[irCR + irPR + irdSD\] based on irRECIST v1.1. irCR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have reduction in their short axis to \<10 mm. irPR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference baseline sum of longest diameter. irSD: neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for irPD, taking as reference smallest sum diameters while on study. irPD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). |
| Secondary | Durable Stable Disease Rate (DSDR) Based on irRECIST Version 1.1 | From first dose date until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | Durable SD rate is defined as the percentage of participants whose observed BOR is irSD and the duration of irSD is \>=23 weeks based on irRECIST v1.1. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib | Cycle 1 (21 days) | The MTD analysis set included all participants who completed Cycle 1 of treatment in Phase 1b or discontinued early due to DLT. | milligram (mg) | NUMBER |
| PRIMARY | Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Cycle 1 (21 days) | The MTD analysis set included all participants who completed Cycle 1 of treatment in Phase 1b or discontinued early due to DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 | Week 24 | The full analysis set (FAS) included all participants who entered the study treatment period. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From date of first dose up to 30 days after the last dose of study drugs (Up to 74 months) | The safety analysis set included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) Based on irRECIST Version 1.1 | From date of first dose of study drug administration until immune related (irPD), development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | The FAS included all participants who entered the study treatment period. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Based on irRECIST Version 1.1 | From date of first dose of study drug administration to date of irPD or date of death, whichever occurred first (up to 73 months) | The FAS included all participants who entered the study treatment period. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the first dose until death from any cause, up to 73 months | The FAS included all participants who entered the study treatment period. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on irRECIST Version 1.1 | From first dose of the study drug until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | The FAS included all participants who entered the study treatment period. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) Based on irRECIST Version 1.1 | From first dose date until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | The FAS included all participants who entered the study treatment period. | percentage of participants | NUMBER |
| SECONDARY | Durable Stable Disease Rate (DSDR) Based on irRECIST Version 1.1 | From first dose date until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months) | The FAS included all participants who entered the study treatment period. As planned, data for this outcome measure dSD rate (where SD\>=23 weeks) was not analyzed and collected separately but was included and analyzed in outcome measure CBR (irCR+irPR+\[irSD duration \>=23 weeks\]). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib | Phase 1b: All Participants | MTD | 20 | milligram (mg) | |
| Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib | Phase 1b: All Participants | RP2D | 20 | milligram (mg) | |
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 1 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC | 1 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib | Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma | 0 | Participants | ||
| Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC | 39.5 | 95% Confidence Interval 30.9 to 48.7 | percentage of participants | |
| Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC | 56.6 | 95% Confidence Interval 48.1 to 64.8 | percentage of participants |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 2 | |
| Overall Study | STARTED | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC | 1 | |
| Overall Study | STARTED | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC | 124 | |
| Overall Study | STARTED | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC | 145 | |
| Overall Study | STARTED | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma | 21 | |
| Overall Study | STARTED | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC | 21 | |
| Overall Study | STARTED | Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC | 22 | |
| Overall Study | STARTED | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC | 20 | |
| Overall Study | STARTED | Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma | 1 | |
| Overall Study | Phase 1b Participants Who Received, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg. | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events3,321
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 | Atrioventricular block first degree | Cardiac disorders | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 1 | 2 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC | 0 | 1 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC | 0 | 124 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC | 0 | 145 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma | 0 | 21 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC | 0 | 21 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC | 0 | 22 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC | 0 | 20 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma | 0 | 1 | 0 |
| other | Ventricular arrhythmia | Cardiac disorders | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 1 | 2 | 1 |
1 to 10 of 3,321Source ClinicalTrials.gov
See all 3,321 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 1 | 2 |
| Total, all-cause mortality | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC | 1 | 1 |
| Total, all-cause mortality | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC | 88 | 124 |
| Total, all-cause mortality | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC | 74 | 145 |
| Total, all-cause mortality | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma | 15 | 21 |
| Total, all-cause mortality | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC | 16 | 21 |
| Total, all-cause mortality | Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC | 15 | 22 |
| Total, all-cause mortality | Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC | 16 | 20 |
| Total, all-cause mortality | Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma | 1 | 1 |
| Total, other adverse events | Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC | 2 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers7
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/NCT02501096
GET https://conductscience.org/api/trials/v1/NCT02501096/results?page=2