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

Not Recruiting

Trial ID: NCT05166577


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

Official Title

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

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Key Inclusion Criteria:

   - Recurrent or metastatic EBV+ nasopharyngeal carcinoma (RM-NPC) for whom no potentially
   curative options are available, who have received at least 1 prior line of
   platinum-based chemotherapy and no more than 3 prior lines of therapy for RM-NPC.

   - Phase 1b exploratory proof-of-concept cohort only: Advanced/metastatic EBV+ non-NPC
   solid tumors with no available curative therapies.

   - Measurable disease per RECIST v1.1

   - ECOG performance status 0 or 1

   - Adequate bone marrow and liver function

Key Exclusion Criteria:

   - Anti-tumor treatment with cytotoxic drugs, biologic therapy, immunotherapy, or other
   investigational drugs within 4 weeks or >5 half-lives, whichever is shorter

   - Active CNS disease

   - Inability to take oral medication, malabsorption syndrome or any other
   gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption
   of nanatinostat and valganciclovir

   - Active infection requiring systemic therapy

   - Active autoimmune disease that has required systemic therapy with modifying agents,
   corticosteroids, or immunosuppressive agents

   - Positive hepatitis B or hepatitis C


drug: Nanatinostat

drug: Pembrolizumab

drug: Valganciclovir

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters

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