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Advanced Adult Hepatocellular CarcinomaPhase 2NCT02409524

An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

A Phase 2 study testing AlloVax, AlloStim and CRCL in people with Advanced Adult Hepatocellular Carcinoma, run by Mirror Biologics, Inc. at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single site, Phase IIA clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Adult Hepatocellular Carcinoma
What is being tested?
AlloVax, AlloStim and CRCL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteThailand
Study dates
Jul 2016to Mar 2019
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

  • Males and females who are at least 18 years of age at time of enrollment
  • Histologically confirmed hepatocellular carcinoma with or without positive HBV and/or HCV, not candidate for local regional intervention
  • Minimum of 90 days of sorafenib treatment or ineligible for sorafenib
  • Child-Pugh Stage A-B (score ≥ 5 and ≤ 9)
  • Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
  • Measurable disease (for mRECIST)
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  • Lesion amenable for percutaneous tumor harvest and follow up biopsy
  • Adequate bone marrow, liver and renal function as assessed by the following:
  • Hemoglobin > 10.0 g/dl
  • Absolute neutrophil count (ANC) > 1,500/mm3
  • Platelet count > 75,000/μl
  • ALT and AST < 2.5 x ULN
  • Alkaline phosphatase < 4 x ULN
  • Serum creatinine < 1.5
  • Women of child-bearing potential: negative pregnancy test
  • Patients of child producing potential: usage of 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 ability to give written informed consent to participate

Who cannot join

  • Severe ascites, massive or uncontrolled (+3 on Child-Pugh calculator)
  • Severe encephalopathy, uncontrolled (+3 on Child-Pugh calculator)
  • INR > 1.5
  • Participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for HCC other than sorafenib
  • Any autoimmune disorder
  • Any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
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  • HIV positive or syphilis
  • History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) or uncontrolled hypertension
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 4.0)
  • History of organ or tissue allograft
  • Advanced liver cirrhosis
  • Interferon or thalidomide within 1 month prior to signing informed consent
  • Uncontrolled concurrent serious medical or psychiatric illness
  • Clinically apparent central nervous system metastases or carcinomatous meningitis
  • History of blood transfusion reactions
  • Known allergy to murine monoclonal antibodies or bovine products or cow milk

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: Phase IIA Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma

This is an open-label, single site, Phase IIA clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients.

Read the detailed description

Hepatocellular carcinoma (HCC) or primary liver cancer is the third leading cause of cancer death worldwide. It accounts for 90% of all liver cancers. More than 80% of patients present with advanced or unresectable disease.

For patients with vascular invasion and/or metastases, the only approved therapy that offers a survival advantage is Sorafenib (Nexavar®). While palliative systemic chemotherapy other than Sorafenib is sometimes offered for HCC, there is no evidence that any chemotherapy has any meaningful therapeutic benefit, especially in overall survival. Subjects in the current study will either have completed at least 90 days of sorafenib treatment or are not able to receive sorafenib due to intolerability or unable to afford. Subjects will continue sorafenib as tolerated while receiving experimental therapy. The experimental dosing schedule has four segments: (1) priming, which consists of intradermal AlloStim alone; (2) vaccination, which consists of intradermal dosing of AlloStim+CRCL; (3) activation, which consists of an intravenous infusion of AlloStim; and (4) booster, which consists of monthly intradermal injections of CRCL alone

Being tested
AlloVax, AlloStim, CRCL

What participants receive

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

  • AlloVaxBiological

    Also called CRCL and AlloStim

    Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)

  • AlloStimBiological

    Also called AlloStim ID, AlloStim IV

    AlloStim (ID) injection AlloStim (IV) infusion

  • CRCLBiological

    Also called Chaperone Rich Cell Lysate

    Autologous tumor-derived chaperone protein mixture

Study groups in NCT02409524
Study groupRoleWhat they receive
TreatmentExperimentalThe treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
Receives: Biological: AlloVax; Biological: AlloStim; Biological: CRCL

What is being measured

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

  1. To evaluate survival compared to historical controls

    Baseline to date of death from any cause

    Measured: Approximately 12 months

Secondary outcomes (3)

  1. To assess AFP as surrogate end-point for response and/or survival

    Biomarker concentration will be evaluated at different time points

    Measured: Approximately 6 months

  2. To assess mRECIST as surrogate end-point for response and/or survival

    Objective tumor responses by mRECIST will be compared with OS

    Measured: Approximately 6 months

  3. To evaluate safety in advanced HCC (adverse events)

    Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events

    Measured: Approximately 6 months

Timeline

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

  1. First posted7 Apr 2015 (estimated)
  2. Study startJul 2016
  3. Primary completionJun 2017
  4. Study completionMar 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02409524
Sponsor's protocol ID
ITL-022-HCC-BKK-VAX+S
Status last verified
Nov 2017
First submitted
1 Apr 2015
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AlloVax, AlloStim and CRCL in people with Advanced Adult Hepatocellular Carcinoma, 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 17 inclusion and 16 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate survival compared to historical controls (time frame: Approximately 12 months). 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 NCT02409524.

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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