NAVAL-1
Research type
Research Study
Full title
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
IRAS ID
1003690
Contact name
Cheryl Madsen
Contact email
Sponsor organisation
Viracta Therapeutics, Inc.
Eudract number
2020-005197-10
Clinicaltrials.gov Identifier
Research summary
This study will enrol patients who have a specific form of blood cancer called lymphoma. The lymphoma is either relapsed or refractory and is associated with a virus called Epstein-Barr virus (EBV). Relapsed means that the cancer has returned after treatment. Refractory means that the cancer is resistant to or has not responded to treatment. EBV+ lymphoma is a cancer of white blood cells called lymphocytes. Lymphocytes normally help the body fight against infection and disease. EBV+ lymphoma means that the tumour cells have Epstein-Barr virus. There are various types of EBV positive (EBV+) lymphoma and eligible participants will have EBV inside of their cancer cells.
The purpose of this research study is to determine the safety and effectiveness of the combination therapy, nanatinostat and valganciclovir, on treating EBV+ lymphoma cancers. The safety and effectiveness of nanatinostat on its own will also be reviewed in a small subset of participants. Regardless of treatment group, no placebo will be used.
Valganciclovir is an anti-viral drug currently approved in the UK and other parts of the world for preventing and treating cytomegalovirus (CMV), which is similar to EBV. Valganciclovir works by preventing virus and cells from replicating. Valganciclovir is a prodrug, which means it is inactive when initially dosed, and is activated by a specific EBV protein. This EBV protein is not expressed in EBV lymphoma, therefore, an investigational drug, nanatinostat, is given to turn on the EBV protein and activate the valganciclovir. This study is investigating the ability of this approach to interfere with the EBV positive tumour cells when they divide, causing them to die.
The study is planned to include approximately 150 people who have EBV+ lymphoma. Males and females aged 18 years and older will be eligible.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0244
Date of REC Opinion
21 Sep 2021
REC opinion
Further Information Favourable Opinion