A Phase 2 Study of Roginolisib in People With Advanced Uveal Melanoma

Full Title

A Phase II, Multi-centre, Open label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib in Patients with Advanced/Metastatic Ocular/Uveal Melanoma

Purpose

Researchers are comparing 2 different doses of roginolisib with standard therapy for uveal melanoma. The people in this study have uveal melanoma that has spread and gotten worse after treatment.

Roginolisib works by blocking a protein called PI3K-delta. By blocking this protein, roginolisib may strengthen your immune system’s ability to fight cancer cells. It is taken orally (by mouth).

If you take part in this study, you will be randomly assigned to get one of these treatments:

• Experimental treatment with roginolisib.
• Standard treatment as chosen by your study doctor.

Who Can Join

To join this study, there are a few conditions. You must:

• Have uveal melanoma that keeps growing after treatment that included immunotherapy.
• Have completed prior anti-cancer treatment at least 2 weeks before getting the study therapy (4 weeks since any radiation therapy).
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Alexander Shoushtari’s office at 646-888-4161.