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Squamous Cell Carcinoma Head and NeckPhase 2NCT02624999

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

A Phase 2 study testing AlloVax™ and Cisplatin in people with Squamous Cell Carcinoma Head and Neck, run by Mirror Biologics, Inc. at 1 site in Thailand.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma Head and Neck
What is being tested?
AlloVax™ and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteThailand
Study dates
Dec 2016to May 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • National Cancer Institute of Thailand

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: 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 .

Read the 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.

Being tested
AlloVax™, Cisplatin
Keywords
Head and Neck Cancer, SCCHN, R/M SCCHN, Carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlloVax™Biological

    Also called CRCL + AlloStim™

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

  • CisplatinDrug

    Also called Standard Chemotherapy

    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

Study groups in NCT02624999
Study groupRoleWhat they receive
ImmunotherapyExperimentalSubjects 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
Receives: Biological: AlloVax™
Standard chemotherapyActive comparatorSubjects 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
Receives: Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 119 days

  2. 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

    Measured: 119 days

Secondary outcomes (1)

  1. Health related Quality of Life (HRQoL)

    QLQ-C30 and QLQ-H\&N35 questionnaires

    Measured: 119 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study startDec 2016 (estimated)
  3. Primary completionDec 2016
  4. Study completionMay 2017

Why it stopped: PI changed institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02624999
Sponsor's protocol ID
ITL-020-HENK-VAXPII
Status last verified
Jul 2016
First submitted
29 Nov 2015
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AlloVax™ and Cisplatin in people with Squamous Cell Carcinoma Head and Neck, run by Mirror Biologics, Inc. at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)) (time frame: 119 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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