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

NCT02624999 | Withdrawn Phase 2

• 1 other identifier: ITL-020-HENK-VAXPII
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma Head and Neck

Keywords

Head and Neck Cancer; SCCHN; R/M SCCHN; Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Health related Quality of Life (HRQoL)

  119 days

Other Outcomes (3)

• RECIST

  119 days

• Immune-Related Response Criteria (irRC)

  119 days

• Immune response in the treatment arm

  119 days

Study Arms (2)

Immunotherapy

EXPERIMENTAL

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™

Standard chemotherapy

ACTIVE COMPARATOR

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

Interventions

AlloVax™ BIOLOGICAL

AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens

Also known as: CRCL + AlloStim™

Immunotherapy

Cisplatin DRUG

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

Also known as: Standard Chemotherapy

Standard chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (1)

National Cancer Institute of Thailand

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Michael Har-Noy, Dr.

  CEO & CTO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 9, 2015
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 22, 2020

Record last verified: 2016-07

Locations

TH (1)