Trial · NCT03898180
Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)
NCT03898180, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-10-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011). Trials, record NCT03898180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03898180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)
- NCT number
- NCT03898180
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 505 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Urothelial Carcinoma
- Interventions
- Pembrolizumab, Lenvatinib, Placebo for lenvatinib
- First posted
- 2019-04-01
- Last updated
- 2026-02-05
- Other registries' IDs
- eudract:2018-003752-21
- Results first posted
- 2023-10-31
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to approximately 25 months | PFS was defined as the time from randomization to the first documented PD per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR), or death due to any cause, whichever occurs 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. PFS as assessed by BICR per RECIST 1.1 is presented. Protocol-specified final analysis for this primary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
| Primary | Overall Survival (OS) | Up to approximately 25 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. Protocol-specified final analysis for this primary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 25 months | ORR was defined as the percentage of participants who had a confirmed CR (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 as assessed by BICR. The percentage of participants who experienced a CR or PR is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
| Secondary | Duration of Response (DOR) | Up to approximately 25 months | For participants who demonstrated a confirmed CR (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 as assessed by BICR, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions as well as an absolute increase of ≥5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR as assessed by BICR per RECIST 1.1 for participants who experienced a confirmed CR or PR is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
| Secondary | Disease Control Rate (DCR) | Up to approximately 25 months | DCR was defined as the percentage of participants who have a CR (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 PD \[PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD\]). DCR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. The DCR as assessed by BICR per RECIST 1.1 is presented. Protocol-specified final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS) (Item 29) and Quality of Life (QOL) (Item 30) Combined Score | Baseline and Week 11 | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding GHS ("How would you rate your overall health during the past week?") and QOL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QOL (EORTC QLQ-C30 Item 30) combined score is presented. A higher score indicates a better outcome. Final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021, as specified in the Supplemental Statistical Analysis Plan (sSAP). |
| Secondary | Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 GHS (Item 29) and QOL (Item 30) Combined Score | Baseline and up to approximately 25 months | TTD was defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) \& QOL (EORTC QLQ-C30 Item 30) combined score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding GHS ("How would you rate your overall health during the past week?") and QOL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QOL combined score, is presented. A longer TTD indicates a better outcome. Final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021, as specified in the sSAP. |
| Secondary | Number of Participants Who Experience an AE | Up to approximately 25 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 could 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 experienced an AE is presented. Final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 25 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 could 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 study treatment due to an AE is presented. Final analysis for this secondary outcome measure was performed with an analysis data cut-off date of Jul-26-2021. |
Source ClinicalTrials.gov
Outcomes9
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) | Up to approximately 25 months | All participants randomized prior to the protocol-specified primary completion analysis data cut-off. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 25 months | All participants randomized prior to the protocol-specified primary completion analysis data cut-off. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 25 months | All participants randomized prior to the protocol-specified primary completion analysis data cut-off. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 25 months | All participants randomized prior to the protocol-specified primary completion analysis data cut-off and who also experienced a confirmed CR or partial response. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 25 months | All participants randomized prior to the protocol-specified primary completion analysis data cut-off. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS) (Item 29) and Quality of Life (QOL) (Item 30) Combined Score | Baseline and Week 11 | All participants who were randomized and received at least one dose of study treatment prior to the primary completion analysis data cut-off and who also had data available from at least 1 EORTC QLQ-C30 Item 29 and 30 assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 GHS (Item 29) and QOL (Item 30) Combined Score | Baseline and up to approximately 25 months | All participants who were randomized and received at least one dose of study treatment prior to the primary completion analysis data cut-off and who also had data available from baseline and ≥1 post-baseline EORTC QLQ-C30 Item 29 and 30 assessments. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience an AE | Up to approximately 25 months | All participants who were randomized and received at least one dose of study treatment prior to the primary completion analysis data cut-off. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 25 months | All participants who were randomized and received at least one dose of study treatment prior to the primary completion analysis data cut-off. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
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) | Pembrolizumab + Lenvatinib | 4.5 | 95% Confidence Interval 4.0 to 6.0 | Months | |
| Progression-free Survival (PFS) | Pembrolizumab + Placebo | 4.0 | 95% Confidence Interval 2.7 to 5.4 | Months | |
| Overall Survival (OS) | Pembrolizumab + Lenvatinib | 11.8 | 95% Confidence Interval 9.1 to 15.1 | Months | |
| Overall Survival (OS) | Pembrolizumab + Placebo | 12.9 | 95% Confidence Interval 9.8 to 17.8 | Months | |
| Objective Response Rate (ORR) | Pembrolizumab + Lenvatinib | 33.1 | 95% Confidence Interval 27.2 to 39.3 | Percentage of Participants | |
| Objective Response Rate (ORR) | Pembrolizumab + Placebo | 28.9 | 95% Confidence Interval 23.3 to 35.1 | Percentage of Participants | |
| Duration of Response (DOR) | Pembrolizumab + Lenvatinib | NA | Full Range NA to NA | Months | |
| Duration of Response (DOR) | Pembrolizumab + Placebo | NA | Full Range NA to NA | Months | |
| Disease Control Rate (DCR) | Pembrolizumab + Lenvatinib | 66.9 | 95% Confidence Interval 60.7 to 72.8 | Percentage of Participants | |
| Disease Control Rate (DCR) | Pembrolizumab + Placebo | 56.2 | 95% Confidence Interval 49.7 to 62.5 | Percentage of Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + Lenvatinib | 251 | |
| Overall Study | STARTED | Pembrolizumab + Placebo | 254 | |
| Overall Study | Treated | Pembrolizumab + Lenvatinib | 247 | |
| Overall Study | Treated | Pembrolizumab + Placebo | 254 | |
| Overall Study | Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo Efficacy Analyses | Pembrolizumab + Lenvatinib | 245 | |
| Overall Study | Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo Efficacy Analyses | Pembrolizumab + Placebo | 242 | |
| Overall Study | Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo Safety Analyses | Pembrolizumab + Lenvatinib | 241 | |
| Overall Study | Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo Safety Analyses | Pembrolizumab + Placebo | 242 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab + Lenvatinib | 2 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab + Placebo | 5 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,056
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 First Course | 48 | 247 | 57 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Pembrolizumab First Course | 64 | 254 | 74 |
| other | Anaemia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab → Pembrolizumab Second Course | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Pembrolizumab → Pembrolizumab Second Course | 0 | 5 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Lenvatinib + Pembrolizumab First Course | 16 | 247 | 17 |
| other | Hyperthyroidism | Endocrine disorders | Placebo + Pembrolizumab First Course | 12 | 254 | 13 |
| other | Hyperthyroidism | Endocrine disorders | Lenvatinib + Pembrolizumab → Pembrolizumab Second Course | 0 | 2 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Placebo + Pembrolizumab → Pembrolizumab Second Course | 0 | 5 | 0 |
| other | Hypothyroidism | Endocrine disorders | Lenvatinib + Pembrolizumab First Course | 98 | 247 | 109 |
| other | Hypothyroidism | Endocrine disorders | Placebo + Pembrolizumab First Course | 27 | 254 | 30 |
1 to 10 of 1,056Source ClinicalTrials.gov
See all 1,056 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib + Pembrolizumab First Course | 178 | 251 |
| Total, all-cause mortality | Placebo + Pembrolizumab First Course | 175 | 254 |
| Total, all-cause mortality | Lenvatinib + Pembrolizumab → Pembrolizumab Second Course | 0 | 2 |
| Total, all-cause mortality | Placebo + Pembrolizumab → Pembrolizumab Second Course | 0 | 5 |
| Total, other adverse events | Lenvatinib + Pembrolizumab First Course | 238 | 247 |
| Total, other adverse events | Placebo + Pembrolizumab First Course | 236 | 254 |
| Total, other adverse events | Lenvatinib + Pembrolizumab → Pembrolizumab Second Course | 1 | 2 |
| Total, other adverse events | Placebo + Pembrolizumab → Pembrolizumab Second Course | 5 | 5 |
| Total, serious adverse events | Lenvatinib + Pembrolizumab First Course | 155 | 247 |
| Total, serious adverse events | Placebo + Pembrolizumab First Course | 116 | 254 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab + Lenvatinib vs Pembrolizumab + Placebo: Number of Participants Who Discontinue Study Treatment Due to an AE | Trial comparisons |
| Pembrolizumab + Lenvatinib vs Pembrolizumab + Placebo: Number of Participants Who Experience an AE | 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.
GET https://conductscience.org/api/trials/v1/NCT03898180
GET https://conductscience.org/api/trials/v1/NCT03898180/events?page=2