Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients With High-Risk Squamous Cell Carcinoma of the Oral Cavity1
Principal Investigator: Jeffrey Herpst, RN, OCN, Gliknik Inc
Description: For this multi-center, randomized, phase 2 study (ClinicalTrials.gov Identifier: NCT02873819), researchers are evaluating whether GL-0817, a peptide immunomodulator targeting MAGE-A3, is safe and efficacious for preventing recurrence among patients with squamous cell carcinoma of the oral cavity.
The study has 2 arms: in the first, patients will receive 7 adjuvant injections of GL-0817 with Poly-ICLC and GM-CSF; cyclophosphamide will also be administered prior to the first 3 injections.
In the second arm, patients will receive Poly-ICLC and GM-CSF only, with placebo in place of cyclophosphamide and GL-0817.
The primary outcome is disease-free interval. Secondary outcomes include disease-free survival, overall survival, and adverse events.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/study/NCT02873819.
Status: This study is open and recruiting patients as of June 16, 2017.
This study is sponsored by Gliknik Inc.
- Clinicaltrials.gov. Safety and efficacy study of GL-0817 (with cyclophosphamide) for the prevention of recurrence of squamous cell carcinoma of the oral cavity. NCT02873819. https://clinicaltrials.gov/ct2/show/study/NCT02873819. Accessed June 16, 2017.