NCT03321630

A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies

A Phase II Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single arm phase II study, to determine the overall response rate for the combination of lenvatinib and pemrolizumab in patients with metastatic gastroesophageal cancer who have progressed on first or subsequent line therapies. Given the significant cross talk between angiogenesis and the immune response, combined therapy with lenvatinib and pemrolizumab in advanced gastroesophageal cancer patient will provide improved outcomes compared to standard treatment with currently approved agents.

Detailed description

The objective of this study is to determine the progression free survival (PFS), overall survival (OS) and toxicity rates in advanced gastroesophageal patients treated with lenvatinib and pemrolizumab.

Conditions

• GastroEsophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib 20 mg orally each day on days 1-7
DRUG	Pembrolizumab	Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg

Timeline

• Start date: 2017-10-24
• Primary completion: 2023-03-10
• Completion: 2024-01-16
• First posted: 2017-10-25
• Last updated: 2024-03-27
• Results posted: 2024-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study