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Squamous Cell Carcinoma of the Oral CavityPhase 2NCT02873819

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 study testing GL-0817, Hiltonol and Sargramostim in people with Squamous Cell Carcinoma of the Oral Cavity, run by Gliknik Inc. at 33 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GL-0817, Hiltonol and Sargramostim
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
33 sitesin 7 countries
Study dates
30 Mar 2017to 25 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent and 6 months after the last dose of study agent; or
  • consistent and correct use of 1 of the following highly effective methods of birth control for one month prior to the start of the study agent and 6 months after the last dose:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • intrauterine device (IUD)
  • intrauterine hormone-releasing system ( IUS)
  • bilateral tubal occlusion
  • vasectomized partner (if vasectomized is the sole sexual partner and has received medical confirmation of surgical success)
  • A male subject who is sexually active with a woman of childbearing potential is eligible to enter the study if he agrees to use effective contraception throughout the study and for 6 months after the last dose of study agent.
  • The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. The subject must provide study specific informed consent prior to any protocol procedures that are not a part of standard care, including consent for assessment of HLA-A2 status, mandatory tissue submission for MAGE-A3 analysis and correlative studies.
  • The subject must be willing to return to the study center for vaccinations and study-related follow up procedures including blood and tumor collections and completion of imaging studies as required by the protocol.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

33 sites in 7 countries.

33 sites in 7 countries

Ukraine11 sites

  • Cherkasy Regional Oncology Center

    Cherkasy

  • Chernihiv Regional Oncology Center

    Chernihiv

  • Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

    Dnipro

  • Ivano-Frankivsk Regional Oncology Center

    Ivano-Frankivsk

  • Communal Non-profit enterprise "Regional Center of Oncology"

    Kharkiv

  • Kyiv Regional Oncology Center

    Kyiv

  • Lviv Regional Clinical Hospital

    Lviv

  • Odesa Regional Oncology Center

    Odesa

  • Poltava Regional Clinical Oncology Center

    Poltava

  • Sumy Regional Clinical Oncology Center

    Sumy

  • Podillia Regional Oncology Center

    Vinnytsia

Other trials in Ukraine

Russia8 sites

  • Clinical Oncology Center

    Omsk

  • Rostov Oncology Research Institute

    Rostov-on-Don

  • Leningrad Regional Oncology Center

    Saint Petersburg

  • Oncology Center of Moskovskiy District

    Saint Petersburg

  • Ogarev Mordovia State University

    Saransk

  • Clinical Hospital #1

    Sterlitamak

  • Republican Clinical Oncology Center

    Ufa

  • Regional Clinical Oncology Hospital

    Yaroslavl

Other trials in Russia

Hungary5 sites

  • National Institute of Oncology

    Budapest

  • Semmelweis University

    Budapest

  • University of Debrecen Clinical Center

    Debrecen

  • Bacs-Kiskun County Teaching Hospital

    Kecskemét

  • Medical Center of the University of Pecs

    Pécs

Other trials in Hungary

Serbia3 sites

  • Institute of Oncology and Radiology of Serbia

    Belgrade

  • Military Medical Academy, Clinic of Maxillofacial Surgery

    Belgrade

  • Oncology Institute of Vojvodina (IOV), Clinic of Medical Oncology

    Kamenitz

Other trials in Serbia

Spain3 sites

  • University Hospital Vall d'Hebron (HUVH)

    Barcelona

  • University Hospital La Paz

    Madrid

  • Parc Tauli Health Corporation

    Sabadell

Other trials in Spain

Poland2 sites

  • Oncology Center of Prof. Franciszek Lukaszczyk in Bydgoszcz

    Bydgoszcz

  • Swietokrzyskie Oncology Center in Kielce

    Kielce

Other trials in Poland

United States1 site

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official 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 Cavity

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.

Being tested
GL-0817, Hiltonol, Sargramostim, cyclophosphamide, Placebo
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GL-0817Drug

    Also called Biropepimut-S

    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

  • HiltonolDrug

    Also called Poly-ICLC

    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

  • SargramostimDrug

    Also called GM-CSF, Leukine

    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

  • cyclophosphamideDrug

    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

  • PlaceboDrug

    Placebo (normal saline) will be administered as per the schedule of cyclophosphamide and GL0817/adjuvants administration

Study groups in NCT02873819
Study groupRoleWhat they receive
GL-0817ExperimentalSubjects in active treatment will be vaccinated with GL-0817 with the adjuvants Poly-ICLC (Hiltonol®) and GM-CSF (Sargramostim, Leukine®) 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at Week 18. Patients will receive IV Cyclophosphamide 1 day prior to the first 3 vaccinations.
Receives: Drug: GL-0817; Drug: Hiltonol; Drug: Sargramostim; Drug: cyclophosphamide
PlaceboPlacebo comparatorSubjects 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free interval

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Disease-free survival (DFS)

    Measured: up to 2 years

  2. Overall survival (OS)

    Measured: up to 5 years

  3. Disease-free interval in a per protocol analysis

    Measured: up to 2 years

  4. Adverse event profile

    Measured: up to week 94

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study start30 Mar 2017
  3. Primary completion17 May 2021
  4. Study completion25 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873819
Sponsor's protocol ID
GL0817-01
Other IDs
2016-001256-22, 2016
Status last verified
Sep 2020
First submitted
8 Aug 2016
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GL-0817, Hiltonol and Sargramostim in people with Squamous Cell Carcinoma of the Oral Cavity, run by Gliknik Inc. at 33 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Ukraine, Russia, Hungary, Serbia, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free interval (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.

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