NCT03417739

A Phase II Study of BVD-523 in Metastatic Uveal Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a targeted therapy called BVD-523 as a possible treatment for advanced uveal melanoma.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved BVD-523 as a treatment for any disease. BVD-523 has been tested in patients with solid tumors to determine the highest dose of BVD-523 that can be safely given to patients. In this research study, the investigators are evaluating the role of BVD-523 in the treatment of patients with uveal melanoma. Genetic changes within metastatic uveal melanoma activate proteins in the MAPK protein signaling pathway which leads to tumor growth. In the laboratory BVD-523 works against one of these proteins called ERK to decrease tumor growth. In this study, the investigators are testing BVD-523 to see if it works to treat metastatic uveal melanoma.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	BVD-523	ERK1 and ERK2 inhibitor

Timeline

• Start date: 2018-03-26
• Primary completion: 2020-05-05
• Completion: 2025-07-16
• First posted: 2018-01-31
• Last updated: 2026-02-25
• Results posted: 2021-11-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study