Squamous Cell Carcinoma Head and Neck
Conditions
Keywords
Head and Neck Cancer, SCCHN, R/M SCCHN, Carcinoma
Brief summary
Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .
Detailed description
All accrued subjects will be randomized 2:1 to AlloVax™ (CRCL + AlloStim™) immunotherapy vs. standard chemotherapy. AlloVax™ is an experimental individualized therapeutic vaccine shown to be active in this study population. 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 flurouracil (5FU) on days 1-4 of the cycle. The immunotherapy arm (Arm 2) will receive immunotherapy (AlloVax™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks. The study is designed and powered to determine if AlloVax™ is not inferior to the active chemotherapy control.
Interventions
BIOLOGICALAlloVax™
AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens
DRUGCisplatin
Subjects in the chemotherapy arm will receive up to 6 cycles of cisplatin on day 0 of the 3-week cycle at dose of 80-100 mg/m2 IV and 1000 mg/m2 IV 5FU on days 1-4 of the cycle
Sponsors
Mirror Biologics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult males and female subjects aged 18 years or older at screening visit. * Histopatholologically or cytologically confirmed diagnosis of locoregionally recurrent unresectable or previously untreated metastatic SCCHN. * Tumor lesion safely accessible for biopsy or surgical excision resulting in a minimum of 0.2 g of tumor sample for CRCL processing. * Subjects must have measurable disease according to revised RECIST v.1.1 guidelines. * Eastern Cooperative Oncology Group (ECOG) ≤1. * Subjects must be screened to be negative for Human Immunodeficiency Virus 1 (HIV1), HBsAg, Hepatitis C (HCV) and Rapid Plasma Reagin (RPR,syphilis). * Subjects must have adequate organ function including: (WBC \>3000/mm3, Platelets \>100,000/mm3, Absolute neutrophil count ≥ 1,500/mm³, Hemoglobin ≥ 10.0 g/dL (transfusion allowed)), Hepatic (Serum Total bilirubin \< 2 x ULN mg/dL, Alanine transaminase (ALT) (SGPT) / Aspartate aminotransferase (AST) (SGOT) ≤3 x upper limit of normal (ULN)), Renal: Serum creatinine (SCR) \<2.0 x ULN, or, Creatinine clearance (CCR) \>30 mL/min. * Pre-study EKG without significant abnormalities. * 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. * If child producing potential age, must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product. * 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
* Clinical evidence or radiological evidence of brain metastasis. * Treated for another primary cancer within 2 years prior to signing inform consent form. * Any concomitant anticancer therapies. * History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs. * Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis). * Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine). * Clinical requirement for systemic steroids or immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month prior to signing inform consent form. * 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. * History of blood transfusion reactions. * Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation. * Female subject is pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability (vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)) | 119 days | Whether AlloVax™ is less toxic than chemotherapy. will be evaluated on the basis of the following parameters: vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT) |
| Overall Survival | 119 days | Whether AlloVax™ is not inferior to the active chemotherapy control (from time of randomization). Subjects are followed for survival during the trial and as long as they are alive after the last study treatment through follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related Quality of Life (HRQoL) | 119 days | QLQ-C30 and QLQ-H&N35 questionnaires |
Other
| Measure | Time frame | Description |
|---|---|---|
| RECIST | 119 days | Response and correlation with pathology assessment |
| Immune-Related Response Criteria (irRC) | 119 days | Response and correlation with pathology assessment |
| Immune response in the treatment arm | 119 days | Correlation of OS with immune response |
Countries
Thailand
Outcome results
None listed