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Non-melanoma Skin CancerPhase 1/2MUSIC-01NCT04410874

Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer

A Phase 1/2 study testing Imvamune in people with Non-melanoma Skin Cancer and Basal Cell Carcinoma, run by Ivan Litvinov at 1 site in Canada.

Terminated

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

Official record
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Trial summary

This study examines the safety and efficacy of using the Imvamune smallpox vaccine in the treatment of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Imvamune
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteCanada
Study dates
16 Nov 2020to 23 May 2023
Phase
Phase 1/2
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

  • Subjects must have histologically confirmed, BCC and/or SCC tumors located on the chest, back, thigh, or arm/forearm.
  • Presence of clinically documented disease. Skin tumor should measure at least 10 mm in size and should be no larger than 5 cm in any axes. There should be no clinical suspicion of metastasis (i.e. no lymphadenopaties and no systemic symptoms).
  • Age > 18 years.
  • Subjects must have a documented ECOG performance status of 0 or 1.
  • Subjects could be treatment naive or could have had previous surgery or radiation
  • Subjects may have had prior radiation therapy. A minimum of 28 days (4 weeks) must have elapsed between the last dose of radiation and date of registration (14 days for a single palliative fraction of radiation to a non-target lesion). Subjects must have recovered from any acute toxic effects from radiation prior to registration (unless grade 1, irreversible and considered not clinically significant).
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  • Previous surgery is permitted. A minimum of 28 days (4 weeks) must have elapsed between any major surgery and date of registration (7 days for minor surgery), provided that wound healing has occurred
  • Each subject must sign a consent form prior to registration/at registration and prior to tests which are study specific.
  • Subjects must be accessible for treatment and follow-up. Subjects registered on this trial must be treated and followed at the McGill University Health Centre (MUHC) or McGill Affiliated/other participating hospitals
  • Laboratory requirements (must be done within 7 days prior to registration or at time of registration) as follows:
  • White blood cell count ≥3.0x10^9/L
  • absolute neutrophils ≥1.5x10^9/L
  • hemoglobin ≥100g/L
  • platelets ≥75x10^9/L
  • INR ≤1.2
  • bilirubin ≤1.5x upper normal limit
  • AST and ALT ≤3.0x upper normal limit
  • serum creatinine ≤1.5x upper normal limit (or creatinine clearance of ≥60mL/min)

Who cannot join

  • Cancers located on cosmetically/functionally important areas (i.e. face, neck, genitalia, hands, feet, and lower legs).
  • Tumor larger than 5 cm in size (any axes).
  • Metastatic disease (or suspicion of metastasis).
  • Tumors arising as part of a genetic syndrome (i.e., Bazex-Dupré-Christol, Basal Cell Nevus Syndrome, Rombo syndromes for BCC or Xeroderma Pigmentosa, Ferguson Smith, Grzybowski, Muir-Tore syndromes for SCC).
  • Immunosuppressed individuals (e.g. organ transplant recipients, patient with inherited immunodeficiencies, HIV+ individuals or individuals receiving immunosuppressive medications for other reasons).
  • Individuals that are not able or willing to sign an informed consent.
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  • Subjects with history of other active or current malignancies requiring active treatment.
  • Patients undergoing concurrent treatments with other anti-cancer therapy or other investigational agents.
  • Subjects with prior treatment with Imvamune
  • Subjects with serious illness or medical condition that would not permit management
  • Subjects with uncontrolled pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction.
  • Pregnant or lactating women. Men or women of childbearing potential who do not agree to use adequate contraception while on trial and 6 weeks following the trial.
  • Subjects using anti-viral medications, steroids, immunosuppressive agents, or immunization (including the flu shot) within 14 days prior to registration. Patients who are at high risk of influenza infection (65 years and older, people of any age with certain chronic medical conditions (such as asthma, diabetes, or heart disease), pregnant women and children younger than 5 years), and who have not received an influenza vaccination during the flu season (i.e., October to May).
  • Subjects with a condition that could have resulted in splenic dysfunction (e.g. splenectomy, sickle cell anemia, radiation to the spleen ≥ 20Gy, congenital asplenism).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre

    Montreal, Quebec

Other trials in Canada

About this study

Official title: MVA-BN Imvamune Smallpox Vaccine Virus for Treatment of Basal Cell Carcinoma, Squamous Cell Carcinomas

This study examines the safety and efficacy of using the Imvamune smallpox vaccine in the treatment of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma).

Read the detailed description

One of the main ways cancer is able to develop is by hiding or evading our immune system which usually detects and kills potential tumor cells. Once cancer has developed the ability to evade the immune system it can continue to grow and become a tumor. One potential strategy currently being researched, called immunotherapy, uses viruses to stimulate an immune response which attacks the tumor.

Imvamune is a live, non-replicating virus used in Canada to vaccinate adults and children against smallpox. It is safe to use in immunosuppressed patients because the virus is unable to replicate and spread past the first infected cell. This makes the Imvamune vaccine a viable candidate for immunotherapy in immunosuppressed patients who are at a much higher (up to 60x) risk of developing non-melanoma skin cancers.

Being tested
Imvamune
Keywords
Skin Cancer, Immunotherapy
Medical subject headings
Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms

What participants receive

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

  • ImvamuneBiological

    Also called MVA-BN Smallpox vaccine, Modified Vaccinia Ankara Smallpox Vaccine

    Imvamune vaccine to be administered (via injection) intratumorally at one of three doses (1x10^7, 1x10^8, or 4x10^8 PFU) twice, 4 days apart (first injection on Day 0 of the study and second injection on Day 4)

Study groups in NCT04410874
Study groupRoleWhat they receive
ImvamuneExperimentalImvamune vaccine to be administered intratumorally at one of three doses on Days 0 and 4 of the study
Receives: Biological: Imvamune

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    The MTD will be defined as the dose at which 2 or more patients experience a grade 3 or 4 adverse event (as defined by NCI Common Terminology Criteria for Adverse Events version 5.0) that is at least "probably related" to the study drug (ex: dose limiting toxicity).

    Measured: 25 days

  2. Objective Tumor Response Rate (ORR)

    Clinical and histological evaluation of the tumor to assess the development of immunity against BCC and/or SCC tumors or their protein markers.

    Measured: 25 days

Secondary outcomes (2)

  1. Viral load in NMSC tumours

    Ability to detect viral infection in the tumor.

    Measured: 25 days

  2. Number of T cells/concentration of antigen specific antibodies

    Ability to elicit increased immunological T/NKT cell mediated response, and antibody response against the tumor.

    Measured: 25 days

Timeline

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

  1. First posted1 Jun 2020
  2. Study start16 Nov 2020
  3. Primary completion23 May 2023
  4. Study completion23 May 2023

Why it stopped: Inability to recruit patients/lack of funding

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410874
Sponsor's protocol ID
2020-4599
Acronym
MUSIC-01
Status last verified
Mar 2024
First submitted
27 May 2020
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Imvamune in people with Non-melanoma Skin Cancer and Basal Cell Carcinoma, run by Ivan Litvinov at 1 site in Canada.

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 18 inclusion and 14 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 7 Mar 2024. 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 Canada. 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 combined 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.

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 stopped early (reason given: Inability to recruit patients/lack of funding). 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?

Maximum Tolerated Dose (MTD) (time frame: 25 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 NCT04410874.

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 7 Mar 2024.

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