SAKK 06/14. A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy

SAKK 06/14. A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy - VPM1002BC in recurrent non-muscle invasive bladder cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45818

Enrollment

Registered

2016-08-11

Start date

2016-09-01

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer recurrent non-muscle invasive bladder cancer

Interventions

Induction: 6 intravesical instillations of VPM1002BC in 6-12 weeks Maintenance: 3 instillations of VPM1002BC at months 3, 6 and 12

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically confirmed diagnosis of recurrent NMIBC Negative cytology (except for CIS) Planned treatment starts 2-6 weeks after last TURB One previous cycle of intravesical BCG (induction phase with at least 5 instillations) not more than 5 years ago for NMIBC Recurrent high-risk NMIBC for progression

Exclusion criteria

Exclusion criteria: Stress urinary incontinence >I°, urge urinary incontinence Active concomitant malignant conditions Primary or secondary immunodeficiencies Positive HIV test Chronic administration of immunosuppressive drugs Uncontrollable urinary tract infection

Design outcomes

Primary

Measure	Time frame
Phase I: Dose limiting toxicity of intravesical VPM1002BC instillations Phase II: Recurrence-free rate in the bladder at 60 weeks	—

Secondary

Measure	Time frame
Time to recurrence in the bladder Time to recurrence Time to progression Overall survival Adverse events Tolerability Quality of Life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)