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Advanced CancerPhase 1NCT02992977

Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced Cancer

A Phase 1 study testing AutoSynVax™ vaccine in people with Advanced Cancer, run by Agenus Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Open-label Phase 1 study of AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
AutoSynVax™ vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
Jan 2017to Dec 2019
Phase
Phase 1
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

  • Prior to vaccine production -
  • Diagnosis of advanced cancer (solid tumor) that:
  • May be receiving or about to start another line of therapy.
  • If on a line of therapy or about to start a new line of therapy, it is anticipated that the treatment may provide short-term tumor control.
  • Available tissue from an archival tissue sample or tissue from a biopsy done during the initial screen, or both. If archival tissue is not available or tissue is not mainly tumor, subjects must be willing to undergo a biopsy or surgery to remove some or all of their tumor for next generation sequencing. New tissue should be obtained prior to starting a new line of therapy, if applicable.
  • Minimum estimated life expectancy of 6 months.
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  • Age 18 years or older.
  • Signed written informed consent to allow transfer of tumor tissue and production of vaccine.
  • Discussion about each patient should occur with the Medical Monitor to confirm eligibility.
  • Prior to Treatment -
  • Patients who had vaccine manufactured but were treated with an additional line of treatment may start vaccine if they continue to meet the remaining eligibility criteria.:
  • Diagnosis of advanced cancer (solid tumor) that is refractory to standard therapies.
  • Signed written informed consent for treatment.
  • Minimum estimated life expectancy of 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status <2.
  • Adequate bone marrow function (absolute neutrophil count [ANC] ≥1,500/mm^3; absolute lymphocyte count [ALC] ≥500/mm^3; platelet count 100,000/mm^3), adequate liver function (serum glutamic oxaloacetic transaminase [SGOT]/aspartate aminotransferase [AST] and alkaline phosphatase <2.5 times the institutional upper limit of normal [IULN], total bilirubin <1.5 mg/dL), and adequate renal function (creatinine <1.5 x IULN).
  • Adequate cardiac function (New York Heart Association [NYHA] class ≤II).
  • All participants (males and females) must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study treatment and for the duration of study participation.
  • Female subjects of childbearing potential should have a negative serum pregnancy test at pre-treatment visit and within 72 hours prior to receiving the first dose of study medication.
  • Female subjects of childbearing potential must agree to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity prior to receiving the first dose of study medication through 30 days after the last dose of study medication.

Who cannot join

  • Subjects must not meet any of the following exclusion criteria at the time of tumor procurement. All exclusion criteria must be confirmed prior to treatment.
  • Diagnosis of immunodeficiency or actively receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Corticosteroid dependency.
  • Requirement for immunosuppressive medication aside from corticosteroids.
  • Active or history of any autoimmune disease (subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
  • History of treated or untreated brain metastases or leptomeningeal spread of disease.
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  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Known medical, psychiatric or substance abuse disorders that would preclude participation in the study.
  • Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known to be positive for human immunodeficiency virus (HIV). Testing is not required in the absence of history or high index of suspicion.
  • Intolerance of prior immunotherapy treatment necessitating cessation of therapy.
  • History of intolerance or allergic reactions attributed to compounds of similar chemical or biologic composition to AutoSynVax™ vaccine or QS-21.
  • Women who are pregnant or breastfeeding.
  • Inability to comply with protocol.
  • Prior to Treatment - Subjects must not meet any of the following exclusion criteria prior to treatment in addition to the other exclusion criteria listed above.
  • Receipt of anticancer medications or investigational drugs within the following intervals before first administration of study drug:
  • ≤14 days for chemotherapy, targeted small molecule therapy, anticancer hormone therapy or radiation therapy. Subjects must also not have had radiation pneumonitis as a result of treatment, and cannot participate in the study if they are on chronic corticosteroids for radiation pneumonitis or other reasons. A 1-week washout is permitted for palliative radiation to non-CNS disease with sponsor approval.
  • Note: Bisphosphonates and denosumab are permitted medications. Novel imaging agents that have Phase 1 safety data and have not demonstrated therapeutic activity are also permitted.
  • ≤28 days for a prior immunotherapy.
  • ≤28 days for prior monoclonal antibody used for anticancer therapy with the exception of denosumab.
  • ≤7 days for immunosuppressive-based treatment for any reason. Systemic corticosteroids are not allowed.
  • Note: Use of inhaled or topical corticosteroid use for radiographic procedures is permitted.
  • Note: Patients receiving physiologic steroid replacement for adrenal insufficiency are eligible (i.e. < 10 mg prednisone per day).
  • Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the sponsor.
  • ≤28 days before the first dose for all other investigational study drugs or devices.
  • Receipt of other investigational agents or other anticancer therapies during treatment with AutoSynVax™ vaccine.
  • Receipt of a live vaccine within 30 days prior to the first dose of trial treatment.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • School of Medicine at the University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 1 Study of Safety and Tolerability of AutoSynVax™ Vaccine as a Single Agent in Subjects With Advanced Cancer

Open-label Phase 1 study of AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer

Read the detailed description

This is an open-label Phase 1 study to determine the safety and tolerability of single-agent treatment with AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer that is refractory to standard therapies and a life expectancy of ≥6 months from the time tissue is obtained. A minimum of 6 (≤20) subjects will be enrolled to receive every other week subcutaneous injection of 240 μg AutoSynVax™ vaccine + 50 μg QS-21 Stimulon® adjuvant for up to 1 year.

Conditions
Advanced Cancer
Being tested
AutoSynVax™ vaccine
Keywords
Vaccine, neoantigen

What participants receive

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

  • AutoSynVax™ vaccineBiological

    AutoSynVax™ vaccine + QS-21 Stimulon® adjuvant

Study groups in NCT02992977
Study groupRoleWhat they receive
AutoSynVax™ vaccineExperimentalAutoSynVax™ vaccine + QS-21 Stimulon® adjuvant
Receives: Biological: AutoSynVax™ vaccine

What is being measured

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

  1. Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)

    AEs, irAEs, according to NCI CTCAE version 4.03.

    Measured: From first administration to 30 days from last dose.

  2. Recommended dose for further development

    After 2 doses (administered every 2 weeks), if there are <2 treatment-limiting toxicities (TLTs) in the first 6 subjects, AutoSynVax™ vaccine will be considered safe for further development.

    Measured: 28 days from first dose

Secondary outcomes (4)

  1. Overall survival (OS)

    Duration of survival

    Measured: From first administration until death, or up to study duration (18 - 24 months)

  2. Progression-free survival (PFS)

    From time of first administration per RECIST v1.1

    Measured: 6 Months after last dose is administered.

  3. Objective response rate (ORR)

    From time of first administration per RECIST v1.1

    Measured: 6 Months after last dose is administered.

  4. T-cell response

    T-cell response to tumor specific neo-epitopes in the vaccine

    Measured: 6 Months after last administration.

Timeline

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

  1. First posted14 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2018
  4. Study completionDec 2019

Why it stopped: To enable development of an enhanced version of the vaccine.

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02992977
Sponsor's protocol ID
C-600-01
Status last verified
May 2020
First submitted
9 Dec 2016
Last updated
2 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AutoSynVax™ vaccine in people with Advanced Cancer, run by Agenus Inc. at 2 sites in United States.

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 20 inclusion and 27 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: stopped early, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 stopped early (reason given: To enable development of an enhanced version of the vaccine.). Results are not available in the source record.

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?

Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability) (time frame: From first administration to 30 days from last dose.). 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 NCT02992977.

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 2 Jun 2020.

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