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

Phase 2

• Conditions: bladder cancer; recurrent non-muscle invasive bladder cancer; 10038597

• Registration Number: NL-OMON45818
• Lead Sponsor: Swiss Group for Clinical cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I: Dose limiting toxicity of intravesical VPM1002BC instillations<br /><br>Phase II: Recurrence-free rate in the bladder at 60 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to recurrence in the bladder<br /><br>Time to recurrence<br /><br>Time to progression<br /><br>Overall survival<br /><br>Adverse events<br /><br>Tolerability<br /><br>Quality of Life </p><br>