Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Infections

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Epstein-Barr Virus Infections

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Jin-Ching Lin, MD.PhD.

No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC) patients. The investigators try to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future therapy improvement.

The stage III NPC patients were the majority group of the patient population of NPC. But most clinical trials focused on the treatment of American Joint Committee on Cancer (AJCC) 7th edition stage IVA/IVB treatment for high risk of recurrence or metastasis. No previous study reported the treatment outcome of stage III NPC patients. The investigators tried to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma EBV DNA assay for future therapy improvement.

We collected the pre-treatment and post-treatment plasma EBV DNA. The plasma EBV DNA assay was analyzed by real time PCR.

Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA

Long-term Treatment Outcome for Stage III Nasopharyngeal Carcinoma Patients and Risk Grouping by Plasma Epstein-Barr Virus DNA

Diagnosis to death to recurrence or metastasis

Diagnosis to death to locoregional failure

Taichung Veterans General Hospital

Symptoms and General Pathology

Digestive System Diseases

Recurrence

Stomach Neoplasms

Sarcoma

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Pembrolizumab

Valganciclovir

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antiviral Agents

Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week

Nanatinostat

Valganciclovir starting at 900 mg orally daily

Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks

Afton Katkov, MSc

A. Dimitrios Colevas, M.D.

Savanna Biedermann

Darrel P Cohen, MD, PhD

This study will evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma

This is an open-label, multicenter Phase 1b/2 study evaluating nanatinostat in combination with valganciclovir alone and in combination with pembrolizumab. Nanatinostat is a selective class I HDAC inhibitor which induces EBV early lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form.

The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) in patients with EBV+ RM-NPC followed by a Project Optimus \| FDA (https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus) cohort to confirm the RP2D. Up to 60 patients with EBV+ RM-NPC will be randomized 1:1 to receive nanatinostat in combination with valganciclovir at the confirmed RP2D with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers in the Phase 2 dose expansion part of the study. Additionally, patients with other EBV+ solid tumors will be enrolled to receive nanatinostat in combination with valganciclovir at the RP2D in a Phase 1b cohort.

A traditional 3+3 dose escalation design followed first by a dose optimization cohort and then by dose expansion with 1:1 randomization to receive nanatinostat and valganciclovir with or without pembrolizumab in Phase 2.

Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC

An Open-Label, Multicenter Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients With Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and in Combination With Pembrolizumab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Viracta Therapeutics, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA	NCT03314051	Nasopharyngeal ... EBV Related Car...		20 Years - 80 Years	Taichung Veterans General Hospital
Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC	NCT05166577	Nasopharyngeal ... EBV-Related Gas... EBV-Related Lei... EBV Related Car... EBV-Related Sar...	Nanatinostat Nanatinostat Valganciclovir Pembrolizumab	18 Years -	Viracta Therapeutics, Inc.

Spots Global Cancer Trial Database for ebv related carcinoma