drugset / Trial / NCT04287829
Pembrolizumab Plus Lenvatinib In Second Line and Third Line Malignant Pleural mesotheLioma Patients
Phase 2
Active not recruiting
58 enrolled
The Netherlands Cancer Institute
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
There is no standard second line treatment in malignant pleural mesothelioma (MPM). Pembrolizumab has shown to be active in in small phase II studies in MPM. Its activity however, is limited, with a response rate up to 20%. Since the arrival of nivolumab plus ipilimumab as first line standard of care treatment in mesothelioma, no treatment options are investigated in this group of patients in the second line. So, there is a need for new treatment combinations with drugs that might exhibit a synergistic interaction with pembrolizumab.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2024-12-05
- Completion
- 2026-03-05
Outcome
Met primary endpoint
paper This study met its primary endpoint, showing high clinical activity of pembrolizumab plus lenvatinib PMID 41308680 ↗
Publications
- Douma LH, van der Noort V, Lalezari F, de Vries JF, Monkhorst K, Smesseim I, Baas P, Schilder B, Vermeulen M, Burgers JA, de Gooijer CJ. Pembrolizumab plus lenvatinib as second-line treatment in patients with pleural mesothelioma (PEMMELA): cohort 2 of a single-arm, phase 2 study. Lancet Oncol. 2025 Dec;26(12):1676-1684. doi: 10.1016/S1470-2045(25)00514-5.
- Douma LH, Lalezari F, van der Noort V, de Vries JF, Monkhorst K, Smesseim I, Baas P, Schilder B, Vermeulen M, Burgers JA, de Gooijer CJ. Pembrolizumab plus lenvatinib in second-line and third-line patients with pleural mesothelioma (PEMMELA): a single-arm phase 2 study. Lancet Oncol. 2023 Nov;24(11):1219-1228. doi: 10.1016/S1470-2045(23)00446-1. Epub 2023 Oct 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |