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

Completed · Phase 2 · Has a placebo group

Conditions studied: Squamous Cell Carcinoma of the Oral Cavity

In brief

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.

Key facts

Study ID: NCT02873819
Run by: Gliknik Inc.
People needed: 80
Starts: 2017-03-30
Expected to finish: 2021-05-25
Last updated by the study team: 2022-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age > 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
Subjects 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 (<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 > 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 < 1
Laboratory values obtained ≤ 14 days prior to randomization:
Absolute neutrophil count (ANC) ≥ 1500/μL (without intervention, e.g., G-CSF)
Platelets ≥ 75,000/μL (without intervention, e.g., transfusion)
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable).
Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN)
AST and ALT ≤ 2 x ULN
Creatinine < 2 x ULN
Bilirubin < 1.5x ULN (except for patients with Gilbert's disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)
A female subject is eligible to enter the study if she is:
not pregnant or nursing; Female participants must not breastfeed during the study and for a period of 30 days following the last dose.
of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following:

You may not qualify if…

Known HIV or hepatitis B/C infection (testing not required). Subjects who are hepatitis C antibody positive may be enrolled if they are confirmed to have a negative viral load at screening.
Subjects with active autoimmune disease or a history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.
Subjects who have used systemic corticosteroids or other immunosuppressants for any condition within 14 days of randomization. Inhaled or topical steroids are permitted.
Any medical condition which would, in the investigator's opinion, compromise the patient's ability to mount an immune response, renders the patient a poor candidate for this trial or could confound the results of the study
Major surgery or traumatic injury within 28 days of randomization
Prior splenectomy or organ allograft
Any other prior, concurrent or planned chemotherapy, immunotherapy, radiotherapy, device, or investigational therapy for this cancer other than those specified in this study.
History of other malignancy (i.e., excluding disease under study) within 3 years of randomization. Exceptions include: adequately-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated non-metastatic prostate cancer.
Known hypersensitivity to GM-CSF, yeast-derived products or any component of the GM-CSF drug product (e.g., mannitol) or poly-ICLC (e.g., carboxymethylcellulose).
Known hypersensitivity to cyclophosphamide, its metabolites or any other components, or known urinary outflow obstruction.

Where it is running

University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
National Institute of Oncology — Budapest, Hungary
Semmelweis University — Budapest, Hungary
University of Debrecen Clinical Center — Debrecen, Hungary
Bacs-Kiskun County Teaching Hospital — Kecskemét, Hungary
Medical Center of the University of Pecs — Pécs, Hungary
Oncology Center of Prof. Franciszek Lukaszczyk in Bydgoszcz — Bydgoszcz, Poland
Swietokrzyskie Oncology Center in Kielce — Kielce, Poland
Clinical Oncology Center — Omsk, Russia
Rostov Oncology Research Institute — Rostov-on-Don, Russia
Leningrad Regional Oncology Center — Saint Petersburg, Russia
Oncology Center of Moskovskiy District — Saint Petersburg, Russia
Ogarev Mordovia State University — Saransk, Russia
Clinical Hospital #1 — Sterlitamak, Russia
Republican Clinical Oncology Center — Ufa, Russia
Regional Clinical Oncology Hospital — Yaroslavl, Russia
Institute of Oncology and Radiology of Serbia — Belgrade, Serbia
Military Medical Academy, Clinic of Maxillofacial Surgery — Belgrade, Serbia
Oncology Institute of Vojvodina (IOV), Clinic of Medical Oncology — Kamenitz, Serbia
University Hospital Vall d'Hebron (HUVH) — Barcelona, Spain
University Hospital La Paz — Madrid, Spain
Parc Tauli Health Corporation — Sabadell, Spain
Cherkasy Regional Oncology Center — Cherkasy, Ukraine
Chernihiv Regional Oncology Center — Chernihiv, Ukraine
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital — Dnipro, Ukraine

Full record on ClinicalTrials.gov

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