NCT02873819

Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity

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 Cavity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Gliknik Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind clinical trial to assess the safety and efficacy of GL-0817 as a means to prevent disease recurrence in patients considered at high-risk following surgery and adjuvant chemoradiotherapy.

Conditions

• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
DRUG	GL-0817	GL-0817, IV at the dose 1.5 mg will be administered 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
DRUG	Hiltonol	Hiltonol will be administered intramuscularly at the dose of 1.4 mg as adjuvant to GL0817, 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
DRUG	Sargramostim	Sargramostim will be administered intramuscularly at the dose of 100 μg/m2, as adjuvant to GL0817, 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
DRUG	cyclophosphamide	cyclophosphamide will be administered IV at a dose of 200 mg/m2 (maximum dose 400 mg) one day prior to first three vaccinations of GL0817 with adjuvants
DRUG	Placebo	Placebo (normal saline) will be administered as per the schedule of cyclophosphamide and GL0817/adjuvants administration

Timeline

• Start date: 2017-03-30
• Primary completion: 2021-05-17
• Completion: 2021-05-25
• First posted: 2016-08-22
• Last updated: 2022-03-08

Locations

33 sites across 7 countries: United States, Hungary, Poland, Russia, Serbia, Spain, Ukraine

Regulatory

• FDA-regulated drug study