NCT04729348

Pembrolizumab And Lenvatinib In Leptomeningeal Metastases

Terminated Phase 2 Last updated 25 July 2025

What this trial tests

Phase 2 trial testing Pembrolizumab in Solid Tumor in 10 participants. Terminated before completion.

Timeline

8 March 2021

Primary endpoint
17 January 2024

17 January 2024

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	8 March 2021
Primary completion	17 January 2024
Estimated completion	17 January 2024
Sites	2 locations across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Lenvatinib (LENVATINIB) — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
• Leptomeningeal Metastasis — all drugs for Leptomeningeal Metastasis →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Solid Tumor or Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this research is to examine if an experimental drug combination impacts the survival rate of individuals with Leptomeningeal Metastases

This research study involves an experimental drug combination.

The names of the study drugs involved in this study are:

* Pembrolizumab
* Lenvatinib

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Leptomeningeal Metastasis: A Review of the Pathophysiology, Diagnostic Methodology, and Therapeutic Landscape.
   Nguyen A, Nguyen A, Dada OT, Desai PD, et al · · 2023 · cited 62× · PMID 37366925 · DOI 10.3390/curroncol30060442
2. Leptomeningeal metastases from solid tumors: A Society for Neuro-Oncology and American Society of Clinical Oncology consensus review on clinical management and future directions.
   Wilcox JA, Chukwueke UN, Ahn MJ, Aizer AA, et al · · 2024 · cited 42× · PMID 38902944 · DOI 10.1093/neuonc/noae103
3. Leptomeningeal Metastases from Solid Tumors: Recent Advances in Diagnosis and Molecular Approaches.
   Pellerino A, Brastianos PK, Rudà R, Soffietti R. · · 2021 · cited 32× · PMID 34207653 · DOI 10.3390/cancers13122888
4. Leptomeningeal Metastases: New Opportunities in the Modern Era.
   Wilcox JA, Li MJ, Boire AA. · · 2022 · cited 25× · PMID 35790709 · DOI 10.1007/s13311-022-01261-4
5. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
6. Diagnostic and Therapeutic Updates in Leptomeningeal Disease.
   Roy-O'Reilly MA, Lanman T, Ruiz A, Rogawski D, et al · · 2023 · cited 22× · PMID 37256537 · DOI 10.1007/s11912-023-01432-2
7. Leveraging Molecular and Immune-Based Therapies in Leptomeningeal Metastases.
   Wilcox JA, Boire AA. · · 2023 · cited 17× · PMID 36474108 · DOI 10.1007/s40263-022-00975-5
8. Leptomeningeal Metastases in Melanoma Patients: An Update on and Future Perspectives for Diagnosis and Treatment.
   Steininger J, Gellrich FF, Engellandt K, Meinhardt M, et al · · 2023 · cited 11× · PMID 37511202 · DOI 10.3390/ijms241411443