Study Comparing AlloVax™ to Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck

An Individualized Cancer Vaccine for Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .

Study Overview

• Status: Withdrawn
• Conditions: Squamous Cell Carcinoma Head and Neck
• Intervention / Treatment: Biological: AlloVax™; Drug: Cisplatin

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • National Cancer Institute of Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunotherapy; Subjects in this arm will receive immunotherapy (AlloVax™: CRCL + AlloStim™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks	Biological: AlloVax™; AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens; Other Names: CRCL + AlloStim™
Active Comparator: Standard chemotherapy; Subjects in this arm 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	Drug: Cisplatin; 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; Other Names: Standard Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability (vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT))	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)	119 days
Overall Survival	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	119 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related Quality of Life (HRQoL)	QLQ-C30 and QLQ-H&N35 questionnaires	119 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
RECIST	Response and correlation with pathology assessment	119 days
Immune-Related Response Criteria (irRC)	Response and correlation with pathology assessment	119 days
Immune response in the treatment arm	Correlation of OS with immune response	119 days

Collaborators and Investigators

• Sponsor: Immunovative Therapies, Ltd.
• Investigators: Study Director: Michael Har-Noy, Dr., CEO & CTO

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 29, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Carcinoma; SCCHN; R/M SCCHN
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: ITL-020-HENK-VAXPII