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Protocol No.1666GCCPrincipal InvestigatorCullen, Kevin
PhasePhase II
Age GroupAdult
TitleA 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
DescriptionExperimental: GL-0817
Subjects in active treatment will be vaccinated with GL-0817 with the adjuvants GM-CSF (granulocyte macrophage colony-stimulating factor, also called sargramostim or Leukine®)
and poly-ICLC (Hiltonol®) 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit. Patients will receive IV Cyclophosphamide 1 day prior to the first 3 vaccinations.

Placebo Comparator: Placebo
Subjects in placebo arm will receive placebo to cyclophosphamide (normal saline solution) followed by Poly-ICLC/GM-CSF/placebo vaccine injections on the same schedule as the GL-0817 cohort.
TreatmentThis 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.
Key EligibilityInclusion Criteria:
-Age greater than or equal to 18 years

-Histologic diagnosis of squamous cell carcinoma of the oral cavity including the lip, floor of mouth, anterior 2/3 of tongue, alveolus and gingiva, buccal mucosa, hard palate and retromolar trigone

-Patients must have undergone primary gross total resection (no re-resected patients are allowed) with fulfillment of at least 1 of the following histologic criteria for high-risk disease:
Histologic involvement of 2 or more regional lymph nodes
Any lymph node with histologic extracapsular extension (ECS)
Close (less than 3mm) or positive surgical margins on microscopic evaluation with no gross residual tumor

-No evidence of locoregional disease or distant metastases at screening. Subjects must have negative scans (CT, CT-PET or MRI) for locoregional recurrence, brain or lung metastases. A negative biopsy will be mandated in patients with a positive scan. Other evaluations should be performed as clinically indicated.

-No history of distant metastases.

-Tumor tissue from surgery or biopsy must be available to determine MAGE-A3 expression for correlative studies.

-Following surgery, the patient must have received external beam radiotherapy (58-66 Gy in 2 Gy fractions, 5 days per week) with concomitant cisplatin starting within 8 weeks of surgery. A brief delay in the initiation of radiotherapy following 8 weeks post-surgery due to administrative reasons (e.g., start of RT on Mondays) may be permitted by the Medical Monitor. The cumulative dose of cisplatin the subject received must be greater than 150 mg/m2. Protocol therapy must be initiated within a period of 4-8 weeks (28-56 days) following the end of RT.

-The patient is, in the investigator's opinion, adequately recovered from the effects of surgery and chemoradiotherapy to participate in this study.

-Blood HLA-A2 phenotype

-ECOG Performance Status less than or equal to 1

-Laboratory values obtained less than or equal to 14 days prior to randomization:
Absolute neutrophil count (ANC) greater than or equal to 1500/microliters (without intervention, e.g., G-CSF)
Platelets greater than or equal to 75,000/microliters (without intervention, e.g., transfusion)
Hemoglobin greater than or equal to 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb greater than or equal to8.0 g/dl is acceptable).
Alkaline phosphatase less than or equal to 2.5 x upper limit of normal (ULN)
AST and ALT less than or equal to 2 x ULN
Creatinine less than 2 x ULN
Bilirubin less than 1.5x ULN (except for patients with Gilbert's disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)

Applicable Disease SitesLip, Oral Cavity and Pharynx
Therapies InvolvedImmunotherapy
Drugs InvolvedGL-0817
Sargramostim (gm-csf)
Treatment TypeTreatment
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