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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06833073




Registration number
NCT06833073
Ethics application status
Date submitted
4/02/2025
Date registered
18/02/2025

Titles & IDs
Public title
A Clinical Study of V940 and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Scientific title
A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
Secondary ID [1] 0 0
2024-517335-46
Secondary ID [2] 0 0
V940-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms 0 0
Non-Muscle Invasive Bladder Neoplasms 0 0
Carcinoma in Situ 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - V940
Treatment: Other - BCG

Experimental: V940 + BCG - Participants receive 1 mg of V940 via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.

Active comparator: BCG - Participants receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.

Experimental: V940 - Participants receive 1 mg of V940 via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.


Treatment: Other: V940
IM injection

Treatment: Other: BCG
Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
BCG Arms: Event-free Survival (EFS)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
V940 Monotherapy Arm: Complete Response Rate (CRR)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
BCG Arms: 12-Month Event-free Survival (EFS)
Timepoint [1] 0 0
Up to approximately 12 months
Secondary outcome [2] 0 0
BCG Arms: 24-Month Event-free Survival (EFS)
Timepoint [2] 0 0
Up to approximately 24 months
Secondary outcome [3] 0 0
Recurrence-free Survival (RFS)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Disease-specific Survival (DSS)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
BCG Arms: 12 Month Overall Survival Rate (OSR)
Timepoint [6] 0 0
Up to approximately 12 months
Secondary outcome [7] 0 0
BCG Arms: 24 Month Overall Survival Rate (OSR)
Timepoint [7] 0 0
Up to approximately 24 months
Secondary outcome [8] 0 0
BCG Arms: Complete Response Rate (CRR)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Duration of Response (DOR)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Time to Cystectomy
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
V940 Monotherapy Arm: 6-Month CRR
Timepoint [11] 0 0
Up to approximately 6 months
Secondary outcome [12] 0 0
V940 Monotherapy Arm: 12-Month CRR
Timepoint [12] 0 0
Up to approximately 6 months
Secondary outcome [13] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [13] 0 0
Up to approximately 21 months
Secondary outcome [14] 0 0
Number of Participants Who Discontinue Study Intervention Due to an AE
Timepoint [14] 0 0
Up to approximately 18 months

Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:

- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology

BCG Arms:

* Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
* Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG

V940 Monotherapy Arm:

* Has CIS +/-papillary non-muscle invasive UC of the bladder
* Is ineligible for, or refusing, any IVESIC therapy
* Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
* Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:

* Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC
* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions
* Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
* Has had a myocardial infarction within 6 months of randomization/allocation
* Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
* Has received prior treatment with a cancer vaccine
* Has immunodeficiency or is receiving chronic systemic steroid therapy
* Has active autoimmune disease that has required systemic treatment in the last 2 years
* Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)

BCG Arms:

* Has current active tuberculosis
* Has a known history of HIV infection

V940 Monotherapy Arm:

- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/09/2031
Actual
Sample size
Target
308
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University ( Site 1801) - Macquarie University
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
Italy
State/province [3] 0 0
Roma

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ModernaTX, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06833073