Newly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity. MedDRA version: 19.0 Level: PT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: IRX-2
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INN not yet proposed see D.3.9.3
Current Sponsor code: IRX-2
Other descriptive name: Primary Cytokine Components: I
Sponsors
IRX Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed diagnosis of Stage II, III or IVA squamous cell cancer of the oral cavity (excluding the lip). 2. Subjects: males or females at least 18 years of age at study entry. 3. Disease is surgically resectable with a curative intent. 4. Karnofsky Performance Status = 70%. 5. Haematological, Hepatic and Renal functions are adequate for surgical intervention. 6. Females of child-bearing potential must have negative urine/serum pregnancy test and agree to used a highly effective form of birth control. 7. Subjects are able to give Informed Consent and adhere to the protocol treatment plan. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Prior surgery, radiation or chemotherapy (excluding biopsy or any procedure required for supportive care). 2. Tumour of the oropharynx. 3. Tumour involvement likely to be associated with T4b cancer. 4. Distant metastased (M1 disease). 5. Diagnosis of another invasive cancer which is currently not in remission and has required treatment within the last 5 years. 6. Known infection with hepatitis B, C or HIV. 7. Use of any Investigational agent within 30 days of randomization. 8. Symptomatic cardiopulmonary disease which are not clinical stable. 9. Myocardial infarction within the last 3 months. 10. Stroke or other cerebral vascular insufficiency within last 3 months. 11. Daily use systemic immunosuppressive therapy or corticosteroids (except for hormone deficiency) 30 days prior to randomization. 12. Known allergies to ciprofloxacin(or other quinolones) acetylsalicylic acid or indomethacin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine if the event-free survival (EFS) of subjects treated with Regimen 1 (IRX-2 Regimen with cyclophosphamide, indomethacin, zinc, omeprazole and IRX-2) is longer than for subjects treated with Regimen 2 (Regimen 1 with cyclophosphamide, indomethacin, zinc, omeprazole but without IRX-2). Key exploratory objectives for the detection of biological activity, prognostic and predictive factors, and clinical-pathologic-immunologic correlates, are included and defined in the protocol. The key exploratory endpoints will be analysed separately from, and not affect the primary endpoint analysis.;Secondary Objective: Secondary objectives are: 1. to determine if OS of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2; 2. to compare the safety of each Regimen; 3. to compare the feasibility of each Booster Regimen.;Primary end point(s): The primary endpoint is event-free survival (EFS). Progression prior to surgical resection will not be considered an Event, but failure to resect tumor that was apparent at randomization for any reason or the presence of gross residual disease at surgery will be considered an Event. Progression after resection should be confirmed by biopsy, but in the absence of biopsy confirmation, unequivocal clinical evidence of progression in the primary or nodal sites or distant metastatic disease using RECIST v1.1 criteria will be accepted as progression. Scans (CT, MRI or PET) should be performed to restage disease and establish patterns of relapse. The date of progression will be the date on which the decision not to resect tumor that was apparent at randomization is made or the date upon which the Investigator first observes recurrent locoregional or metastatic disease by physical or radiologic examination. Death for any cause will also be considered an Event. Diagnosis of a second malignancy will not be considered an Event, but date of diagnosis, site and histology will be | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are overall survival (OS) and safety and feasibility. Survival data will be collected in all subjects (phone contact after progression will be sufficient). When the subject comes to clinic and/or is contacted by phone, the date of that contact is to be reported as an update of the subject’s survival. Safety of each Regimen and feasibility of the Booster Regimens will be assessed by the incidence and severity of AEs, SAEs, and subject discontinuations.;Timepoint(s) of evaluation of this end point: Survival data will be collected at each study visit after surgery at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, and 48 months with telephone calls for survival status to occur every 3 months if subject is not seen in follow-up until data collection ceases. All subjects will be assessed for AEs as detailed in the study schedule. AEs will be measured from day of randomisation until 30 days post-surgery and subsequently from the first day of each booster Regimen until 30 days after the completion. SAEs will be measured from day of randomization until the subject ends the trial. | — |
Countries
Brazil, Canada, Germany, Hungary, Italy, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactPivotal Medical Department
Pivotal, S.L.
Outcome results
None listed