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

NCT05037279 | Recruiting Phase 3 DMC

• 1 other identifier: VRT-BCG-01
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 6

Brief 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 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.

Conditions

Urothelial Carcinoma Recurrent; Non-Invasive Bladder Urothelial Carcinoma; Bladder Cancer; Bladder Cancer Recurrent; Neoplasm Recurrence; Urothelial Carcinoma Bladder

Keywords

Interventional; Non-inferiority study

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (6)

• Recurrence Free Survival (RFS)

  36 months

• Progression Free Survival (PFS)

  24 months

• Progression Free Survival (PFS)

  36 months

• Overall Survival (OS)

  36 months

• Change in Quality of Life

  36 months

Other Outcomes (3)

• Safety: Incidence of treatment-emergent AEs and SAEs

  36 months

• Safety: Number of discontinued subjects

  36

• Safety: concomitant medications

  36 months

Study Arms (2)

Verity-BCG

EXPERIMENTAL

* Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I * Freeze-dried powder for bladder instillation

Drug: Bacillus Calmette-Guerin: Strain Russian BCG-I

OncoTICE

ACTIVE COMPARATOR

* Standard of Care * Bacillus Calmette-Guérin (BCG): Strain TICE * Freeze-dried powder for bladder instillation

Drug: Bacillus Calmette-Guerin: Strain TICE

Interventions

Bacillus Calmette-Guerin: Strain Russian BCG-I DRUG

* 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.

Also known as: Verity-BCG

Verity-BCG

Bacillus Calmette-Guerin: Strain TICE DRUG

* 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.

Also known as: OncoTICE

OncoTICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• 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.
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Verity Pharmaceuticals Inc.: lead

Study Sites (6)

Site 05

Vancouver, British Columbia, Canada

RECRUITING

Site 04

Kingston, Ontario, Canada

RECRUITING

Site 01

Toronto, Ontario, Canada

RECRUITING

Site 02

Toronto, Ontario, Canada

NOT YET RECRUITING

Site 08

Toronto, Ontario, Canada

RECRUITING

Site 10

Montreal, Quebec, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Girish S Kulkarni, MD

  Princess Margaret Cancer Centre, 700 University Ave, 6-824 Toronto, ON, M5G 1X6, Canada

  PRINCIPAL INVESTIGATOR

• Alexandre R Zlotta, MD, PhD, FRCSC

  Mount Sinai Hospital, 600 University Avenue, Toronto, ON, M5G 1X5

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taniya Mann, PhD, MBA

CONTACT

800-977-9778; medinfo@veritypharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 8, 2021
• Study Start: April 24, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)