Clinical trial · no report yet · Phase 3
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 ↗
- Completed
- Merck Sharp & Dohme LLC
- 14 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 11 | |
| YouTube | 2 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- 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)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Urothelial Carcinoma
- Interventions
- Pembrolizumab; Lenvatinib; Placebo for lenvatinib
- Arms
- Pembrolizumab + Lenvatinib · Experimental
- Pembrolizumab + Placebo · Active comparator
- Enrollment
- 505
- Primary outcomes
- Progression-free Survival (PFS)
- Overall Survival (OS)
- Sponsor
- Merck Sharp & Dohme LLC with Eisai Inc.
- Start
- May 6, 2019
- Primary completion
- Jul 26, 2021
- Results posted
- Yes
- Registry record
- NCT03898180 · updated Feb 5, 2026
Publications
linked from the registry- Matsubara N, de Wit R, Balar AV, Siefker-Radtke AO, Zolnierek J, Csoszi T, Shin SJ, Park SH, Atduev V, Gumus M, Su YL, Karaca SB, Cutuli HJ, Sendur MAN, Shen L, O'Hara K, Okpara CE, Franco S, Moreno BH, Grivas P, Loriot Y. Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial. Eur Urol. 2024 Mar;85(3):229-238. doi: 10.1016/j.eururo.2023.08.012. Epub 2023 Sep 29. PubMed 37778952
- Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10. PubMed 33300372