An Open-label, Single-arm, Multi-institutional Phase II Trial of Avelumab for Recurrent, Metastatic Nasopharyngeal Carcinoma
The purpose of this study is to determine whether avelumab, an investigational antibody against programmed death-ligand (PD-L1), has an effect on recurrent nasopharyngeal cancer. Avelumab is designed to block the interaction between programmed cell death protein 1 (PD-1), a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer.
* Patient has histologically/cytologically confirmed, non-keratinizing/undifferentiated, EBV-related nasopharyngeal carcinoma, not amenable to curative intent therapy. EBV testing may be completed per institutional standards.
* Patient must have at least one measurable site of disease as defined by RECIST v1.1, determined by investigator review
* Patient has received at least one prior line of systemic therapy in the recurrent/metastatic setting
* Patient is willing to undergo a fresh tumor biopsy (core or excisional) for correlative analyses (ie. PD-L1 expression).The study chair may grant exceptions to the mandatory biopsy should the treating physician deem that a biopsy is not feasible or unsafe for the patient, and archival tissue is available and provided for study purposes. A conversation with the study chair is required to obtain an exception.
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
* Patient has adequate organ and marrow function (absolute neutrophil count ≥ 1000, hemoglobin ≥ 8.0 gram/deciliter (g/dL), platelet count ≥ 75,000, total bilirubin ≤1.5 times institution's upper limit of normal, AST/SGOT and ALT/SPGT ≤ 2.5 times institutional upper limit of normal, albumin ≥ 2.0 g/dL, serum creatinine ≤ 1.5 times institutional upper limit of normal or creatinine clearance ≥ 30 milliliters per minute (mL/min) according to Cockroft-Gault formula, or local institutional standard method)
* Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
Oral, Head and Neck
Rom Leidner, M.D.
University of California San Diego (UCSD)
- Oncology and Hematology Care Eastside