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Bladder CancerPhase 3EVERNCT05037279

Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)

A Phase 3 study testing Bacillus Calmette-Guerin: Strain Russian BCG-I and Bacillus Calmette-Guerin: Strain TICE in people with Bladder Cancer and Bladder Cancer Recurrent, run by Verity Pharmaceuticals Inc. at 6 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bacillus Calmette-Guerin: Strain Russian BCG-I and Bacillus Calmette-Guerin: Strain TICE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
6 sitesCanada
Study dates
24 Apr 2024to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Male or Female
  • 18 years and older
  • Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification and Grade 2 or 3 in the 1973 classification, diagnosed within 45 days of registration.
  • Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 45 days of registration.
  • Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days of registration, to confirm stage T1N0M0 disease.
  • For patients with stage T1 disease, a repeat TURBT must be performed as per standard of care/CUA guidelines. A repeat TURBT may also be required for patients with Ta disease. Repeat TURBT must be performed within 60 days of the initial TURBT and within 45 days of registration. Pathological confirmation is required after the repeat TURBT.
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  • Patients may have intermediate or high recurrence risk disease, as indicated by the probability of 2-year recurrence of ≥ 50% based on the EORTC Bladder Cancer risk calculator.
  • ECOG performance status of 0-2
  • Adequate organ and marrow function as defined below:
  • leukocytes ≥3,000/mcL
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
  • creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use of BCG at lower kidney function values, no lower than 30 mL/min/1.73 m2
  • For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during 120 days after the last dose of the study treatment. Note: The use of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse 120 days after last dose of study drug treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
  • Note: A woman of non-childbearing potential is defined as follows:
  • Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);
  • Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).
  • Male patients with female partner of childbearing potential must agree to be abstinent or practice an effective method of contraception.
  • Male patients must agree to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment.

Who cannot join

  • Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed within 12 months of the start of treatment. Should the imaging or biopsy be performed outside the window it will be up to the physicians' discretion to re-scan/biopsy. This is considered T4 disease.
  • CIS only disease.
  • Pure squamous cell carcinoma or adenocarcinoma.
  • Presence of micropapillary components.
  • Other prior non-bladder malignancy, except for the following:
  • patients presenting with NMIBC recurrent tumor(s)
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  • adequately treated basal cell or squamous cell skin cancer.
  • in situ cervical cancer.
  • adequately treated stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease free for five years.
  • patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
  • Prior intravesical BCG or intradermal BCG, within 5 years of screening, with the exception of tuberculosis vaccination in childhood.
  • Chronic administration of steroids (>10 mg prednisone) at the time of randomization.
  • Current or planned concomitant biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
  • Prior chemoradiation treatment (trimodal therapy or "TMT") for bladder cancer.
  • Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
  • Receiving any other investigational agents.
  • The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.
  • Known positive HIV serology with detectable viral load.
  • Current diagnosis of AIDS
  • Presence of a urinary tract infection; treatment should be withheld until urine culture is negative and antibiotic therapy is stopped.
  • Trauma to the urinary bladder. In case of gross hematuria, therapy should be stopped or postponed until the hematuria has been successfully treated or has resolved.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
  • Uncontrolled intercurrent illness.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnancy: pregnant women are excluded from this study because VERITY-BCG is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with VERITY-BCG, breastfeeding should be discontinued if the mother is treated with VERITY-BCG.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taniya Mann, PhD, MBA contact

800-977-9778

medinfo@veritypharma.com

6 sites in 1 country

Canada6 sites, 6 recruiting

  • Site 04

    Kingston, Ontario

    Principal Investigator

    Recruiting

  • Site 10

    Montreal, Quebec

    Principal Investigator

    Not yet recruiting

  • Site 01

    Toronto, Ontario

    Principal Investigator

    Recruiting

  • Site 02

    Toronto, Ontario

    Principal Investigator

    Not yet recruiting

  • Site 08

    Toronto, Ontario

    Recruiting

  • Site 05

    Vancouver, British Columbia

    Principal Investigator

    Recruiting

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.

The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.

Read the detailed description

This study is a randomized, active control, double-blind clinical trial aimed at demonstrating non - inferiority of VERITY-BCG to OncoTICE, the current standard of care, with respect to two-year Recurrence Free Survival (RFS) rates in NMIBC BCG - naïve patients that are at high risk for recurrence (defined as >50%).

  • Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.
Being tested
Bacillus Calmette-Guerin: Strain Russian BCG-I, Bacillus Calmette-Guerin: Strain TICE
Keywords
Interventional, Non-inferiority study
Medical subject headings
Urinary Bladder Neoplasms, Recurrence

What participants receive

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

  • Bacillus Calmette-Guerin: Strain Russian BCG-IDrug

    Also called Verity-BCG

    • Induction: 80 mg weekly for 6 weeks.
    • Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
    • Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

  • Bacillus Calmette-Guerin: Strain TICEDrug

    Also called OncoTICE

    • Induction: 50 mg weekly for 6 weeks.
    • Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
    • Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.
Study groups in NCT05037279
Study groupRoleWhat they receive
Verity-BCGExperimental* Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I * Freeze-dried powder for bladder instillation
Receives: Drug: Bacillus Calmette-Guerin: Strain Russian BCG-I
OncoTICEActive comparator* Standard of Care * Bacillus Calmette-Guérin (BCG): Strain TICE * Freeze-dried powder for bladder instillation
Receives: Drug: Bacillus Calmette-Guerin: Strain TICE

What is being measured

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

  1. Recurrence Free Survival (RFS) at 24 months

    Cumulative Recurrence Free Survival (RFS) at 24 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

    Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

    Measured: 24 months

Secondary outcomes (6)

  1. Recurrence Free Survival (RFS)

    Cumulative Recurrence Free Survival (RFS) at 36 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

    Measured: 36 months

  2. Progression Free Survival (PFS)

    Progression Free Survival (PFS) at 24 months as estimated using the Kaplan - Meier estimator of the survival function.

    Measured: 24 months

  3. Progression Free Survival (PFS)

    Progression Free Survival (PFS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

    Measured: 36 months

  4. Overall Survival (OS)

    Overall Survival (OS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

    Measured: 36 months

  5. Change in Quality of Life

    Change in Quality of Life as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for NMIBC (EORTC-QLQ-NMIBC24) and the Bladder Utility Symptom Scale (BUSS) over 36 months.

    The EORTC QLQ-NMIBC24 is a 24-item self-administered questionnaire that measures health-related quality of life in patients with intermediate to high-risk NMIBC. Items are ranked by the patient from 1 to 4 indicating the extent to which they have experienced those symptoms or problems. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

    High Score is equivalent to more problems, except for items on sexual function and sexual enjoyment for which a high score is interpreted as better function.

    The BUSS is a 10-item self-administered questionnaire that measures day to day health-related quality of life in patients with intermediate to high-risk NMIBC

    Measured: 36 months

  6. Change in functioning and symptom status

    Change in functioning and symptom status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for Cancer Patients (EORTC-QLQ-C30) over 36 months.

    The EORTC QLQ-C30 consists of 30 items and measures Health Related Quality of Life as well as presence of symptoms across all cancer types. The QLQ-C30 includes nine multi-item scales:

    • 5 functional scales (physical, role, cognitive, emotional, and social)
    • 3 symptom scales (fatigue, pain, and nausea and vomiting);
    • A global health and quality-of-life scale*
    • Several single-item symptom measures 28 Items are ranked 1 to 4. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much. *2 items are ranked 1 to 7. 1=Very Poor, 7 = Excellent.

    High score = More symptoms or worse problems

    *High Score = Better overall health or Quality of life.

    Measured: 36 months

Timeline

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

  1. First posted8 Sep 2021
  2. Study start24 Apr 2024
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037279
Sponsor's protocol ID
VRT-BCG-01
Acronym
EVER
Status last verified
Mar 2026
First submitted
28 Jul 2021
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participants will only be identified by a code number. Sponsor may share anonymized study data with their commercial partners. All parties will respect the confidentiality rules in effect.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bacillus Calmette-Guerin: Strain Russian BCG-I and Bacillus Calmette-Guerin: Strain TICE in people with Bladder Cancer and Bladder Cancer Recurrent, run by Verity Pharmaceuticals Inc. at 6 sites 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 21 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Taniya Mann, PhD, MBA (800-977-9778, medinfo@veritypharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (RFS) at 24 months (time frame: 24 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 NCT05037279.

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 20 Mar 2026.

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