Subjects at least 18 years of age with histopatholologically or cytologically confirmed distant metastatic or locoregionally recurrent squamous cell carcinoma of the head and neck (R/M SCCHN). Approxi Head and Neck Cancer
Conditions
Interventions
The standard chemotherapy arm (Arm 1) will receive up to six three-
week cycles of chemotherapy consisting of cisplatin on day 0 of the 3-
week cycle at dose 80-
100 mg/m2 IV followed by 1000 mg/m2 IV 5FU on days 1-
4 of the cycle,The immunotherapy arm (Arm 2) will receive immunotherapy (AlloVaxTM) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks.
Cisplatin + 5FU,AlloStimTM
Sponsors
Immunovative Therapies Ltd.
Immunovative Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 0 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study: 1. Adult males and female subjects aged 18 years or older at screening visit. 2. Histopatholologically or cytologically confirmed diagnosis of locoregionally recurrent unresectable or previously untreated metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). 3. Tumor lesion safely accessible for biopsy or surgical excision resulting in a minimum of 0.2 g of tumor sample for CRCL processing. 4. Subjects must have measurable disease according to revised RECIST v.1.1 guidelines. 5. ECOG ≤1. 6. Subjects must be screened to be negative for HIV1, HBsAg, HCV and RPR (syphilis). After confirmation that subject is negative for these agents, the tumor can be processed into CRCL. The tests results ideally should be obtained prior to conducting a tumor harvest procedure, but in any case prior to CRCL manufacture. 7. Subjects must have adequate organ function including: 7.1. Marrow: o WBC >3000/mm3 o Platelets >100,000/mm3 o Absolute neutrophil count ≥ 1,500/mm³ o Hemoglobin ≥ 10.0 g/dL (transfusion allowed) 7.2. Hepatic: o Serum Total bilirubin 30 mL/min. 8. Pre-study EKG without significant abnormalities. 9. Women of child-bearing potential must have a negative urine or serum pregnancy test result within 72 hours prior to the start of study drug administration. 10. If child producing potential age, must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product. 11. Ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects with any of the following will be excluded from the participation in the study: 1. Clinical evidence or radiological evidence of brain metastasis. 2. Treated for another primary cancer within 2 years prior to signing inform consent form. 3. Any concomitant anticancer therapies. 4. History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs. 5. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis). 6. Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine). 7. Clinical requirement for systemic steroids or immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month prior to signing inform consent form. 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia. All infections must be resolved and the subject must remain a febrile for seven days prior to being placed in the study. 9. History of blood transfusion reactions. 10. Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation. 11. Female subject is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability and overall survival (OS) will be the primary endpoints of this study At the end of study A complete efficacy and safety analysis of all clinical data will be performed at the end of the stu | — |
Secondary
| Measure | Time frame |
|---|---|
| Health Related Quality of Life (HRQoL) At the end of study HRQoL Questionnaire | — |
Countries
Thailand
Contacts
Public ContactNitiya Ritthidechratn
Immunovative Thailand
Outcome results
None listed