RWF_UCSD 160114

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.


Inclusion Criteria:

* 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
Phase II
NCT02875613
Oncology
Oral, Head and Neck
Rom Leidner, M.D.
University of California San Diego (UCSD)
George Morris
  • Oncology and Hematology Care Eastside