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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06816017




Registration number
NCT06816017
Ethics application status
Date submitted
4/02/2025
Date registered
10/02/2025

Titles & IDs
Public title
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Scientific title
A Phase I/II, Open-label, Dose Escalation and Extension Study of Intravesical Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Secondary ID [1] 0 0
2024-515410-41-00
Secondary ID [2] 0 0
BP45381
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-muscle Invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eciskafusp Alfa
Treatment: Drugs - BCG Medac Strain

Experimental: Phase I: Dose Escalation - Participants will receive multiple ascending doses of eciskafusp alfa in combination with a fixed dose of BCG administered as an intravesicular instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.

Experimental: Phase II: Dose Extension (Cohort A) - Participants will receive eciskafusp alfa at the maximum tolerated dose (MTD) and/or the recommended dose for extension (RDE), as determined in Phase 1, in combination with a fixed dose of BCG administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.

Experimental: Phase II: Dose Extension (Cohort B) - Participants will receive eciskafusp alfa as monotherapy at the MTD or RDE determined in Phase 1, administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.


Treatment: Drugs: Eciskafusp Alfa
Participants will receive eciskafusp alfa via intravesical instillation.

Treatment: Drugs: BCG Medac Strain
Participants will receive BCG via intravesical instillation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I: Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26)
Primary outcome [2] 0 0
Phase I: Number of Participants With Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
From Day 1 up to Day 14
Primary outcome [3] 0 0
Phase I: Recommended Dose for Extension (RDE) of Eciskafusp Alfa in Combination With BCG
Timepoint [3] 0 0
At Month 25
Primary outcome [4] 0 0
Phase II (Cohort A): Complete Response Rate (CRR) at 12 Months
Timepoint [4] 0 0
At Month 12
Secondary outcome [1] 0 0
Phase I and Phase II: CRR at any Time
Timepoint [1] 0 0
Up to Month 36
Secondary outcome [2] 0 0
Phase I and Phase II: CRR at 6, 18 and 24 Months
Timepoint [2] 0 0
At Months 6, 18 and 24
Secondary outcome [3] 0 0
Phase I and Phase II (Cohort B): CRR at 12 Months
Timepoint [3] 0 0
At Month 12
Secondary outcome [4] 0 0
Phase I and Phase II: Duration of Response (DOR)
Timepoint [4] 0 0
Time from the first occurrence of a documented CR until the time of evidence that the participant no longer meets the definition for CR or death from any cause, whichever occurs first (up to Month 36)
Secondary outcome [5] 0 0
Phase I and Phase II: DOR Rate at Specific Timepoints
Timepoint [5] 0 0
At Months 6, 12, 18, 24, 30 and 36
Secondary outcome [6] 0 0
Phase I and Phase II: Time to Worsening of NMIBC Grade or Stage, or Death
Timepoint [6] 0 0
Time from the first dose of study treatment to the first occurrence of documented worsening of grade, stage or death from any cause, whichever occurs first (up to Month 36)
Secondary outcome [7] 0 0
Phase I and Phase II: Progression Free Survival (PFS) to Muscle Invasive or Metastatic Disease or Death
Timepoint [7] 0 0
Time from the first dose of study treatment to the first occurrence of documented muscle-invasive or metastatic disease or death from any cause, whichever occurs first (up to Month 36)
Secondary outcome [8] 0 0
Phase I and II: Time to Cystectomy
Timepoint [8] 0 0
Time from the first dose of study treatment to the first occurrence of documented cystectomy or death from any cause, whichever occurs first (up to Month 36)
Secondary outcome [9] 0 0
Phase II: Number of Participants With AEs
Timepoint [9] 0 0
From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26)
Secondary outcome [10] 0 0
Phase I and Phase II: Number of Participants With Anti-drug Antibodies (ADAs) to Eciskafusp Alfa
Timepoint [10] 0 0
Up to Month 36
Secondary outcome [11] 0 0
Phase II: Programmed Cell Death Ligand 1 (PD-L1) Expression in the Tumor Microenvironment (TME) Pre-treatment and During the Study
Timepoint [11] 0 0
Predose (-12 weeks to -14 days or archival) and Postdose at Month 6
Secondary outcome [12] 0 0
Phase II: Number of Participants With Cluster of Differentiation 8+ (CD8+) T cell in TME
Timepoint [12] 0 0
Predose (-12 weeks to -14 days or archival)
Secondary outcome [13] 0 0
Phase II: Baseline Urine Tumor Deoxyribonucleic Acid (DNA)
Timepoint [13] 0 0
Baseline (Day 1 predose)
Secondary outcome [14] 0 0
Phase II: Amount of Urine Tumor DNA at Baseline and During the Study
Timepoint [14] 0 0
Up to Month 25

Eligibility
Key inclusion criteria
* Pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to World Health Organization (WHO) grading system
* Absence of resectable disease after transurethral resection of bladder tumor (TURBT) procedures
* The most recent cystoscopy/TURBT must have been performed within 12 weeks and up to 14 days of the first dose of study treatment
* Presence of BCG-unresponsive disease defined as persistent or recurrent carcinoma in situ [CIS] (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG therapy
* The participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure.
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Positive hepatitis B surface antibody (HBsAb) test at screening
* Negative hepatitis C virus (HCV) antibody test at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Active infections (both systemic and local urinary)
* Congenital or acquired immune deficiencies resulting in immunosuppression
* Known human immunodeficiency virus (HIV) infection
* History of radiotherapy of the bladder
* History of perforation of the bladder
* Major surgery or significant traumatic injury within 28 days prior to first administration of study treatment or anticipation of the need for major surgery during treatment
* Participants currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, and supportive care therapies for active disease
* Any intervening intravesical immunotherapy or chemotherapy from the time of the most recent cytoscopy/TURBT to the start of study treatment
* Systemic immune-modulating and systemic immunosuppressive agents/medication
* Administration of a live, attenuated vaccine within 28 days prior to first administration of study treatment
* Recurrence of BCG unresponsive CIS > 12 months after last BCG instillation
* Concurrent second malignancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
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
20/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2030
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP45381 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S.)
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/NCT06816017