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)
Public ClinicalTrials.gov record NCT03898180. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: 1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and 2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). Based on recommendation of the external Data Monitoring Committee (eDMC), Amendment 3 (effective: September \[Sep\]-24-2021) was implemented to unblind the study and discontinue lenvatinib and placebo treatment. The eDMC was then disbanded. With Amendment 4 (effective: December-5-2022) second course pembrolizumab will no longer be offered. Any participant receiving second course pembrolizumab treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. Study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up.
Study identification
- NCT ID
- NCT03898180
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 505 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Lenvatinib Drug
- Placebo for lenvatinib Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 6, 2019 (Actual)
- Primary completion
- Jul 26, 2021 (Actual)
- Completion
- May 20, 2024 (Actual)
- Last update posted
- Feb 5, 2026
2019 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0016) | Gilbert | Arizona | 85234 | — |
| Community Cancer Institute ( Site 0777) | Clovis | California | 93611 | — |
| University of California Irvine Medical Center ( Site 0078) | Orange | California | 92868 | — |
| John Wayne Cancer Institute ( Site 0017) | Santa Monica | California | 90404 | — |
| Northwest Georgia Oncology Centers PC ( Site 0707) | Marietta | Georgia | 30060 | — |
| University of Chicago ( Site 0039) | Chicago | Illinois | 60637 | — |
| Joliet Oncology Hematology ( Site 0091) | Joliet | Illinois | 60436 | — |
| Quincy Medical Group ( Site 0022) | Quincy | Illinois | 62301 | — |
| New England Cancer Specialists ( Site 0047) | Scarborough | Maine | 04074 | — |
| Karmanos Cancer Institute ( Site 0712) | Detroit | Michigan | 48201 | — |
| Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095) | St Louis | Missouri | 63141 | — |
| Comprehensive Cancer Centers of Nevada ( Site 0005) | Las Vegas | Nevada | 89169 | — |
| St. Peter's Hospital Cancer Care Center ( Site 0042) | Albany | New York | 12208 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002) | New York | New York | 10016 | — |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774) | Tulsa | Oklahoma | 74146 | — |
| Thomas Jefferson University Hospital ( Site 0051) | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina-Hollings Cancer Center ( Site 0029) | Charleston | South Carolina | 29425 | — |
| Baylor Scott & White Medical Center - Temple ( Site 0706) | Temple | Texas | 76508 | — |
| Virginia Cancer Institute ( Site 0099) | Richmond | Virginia | 23230 | — |
| Seattle Cancer Care Alliance ( Site 0003) | Seattle | Washington | 98109 | — |
| Cancer Care Northwest ( Site 0009) | Spokane | Washington | 99218 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 173 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03898180, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 5, 2026 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03898180 live on ClinicalTrials.gov.