VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial will assess the safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of VPM1002BC will be compared to results previously reported for BCG in a similar population. The quality of life will be also investigated as a secondary endpoint. Additional immunology assessments are foreseen as exploratory analyses to investigate the immunogenicity of VPM1002BC.

The Phase II of the trial has been opened on 27.07.2016.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of recurrent NMIBC (urothelial carcinoma) including repeat TURB confirming tumor-free state of the bladder (confirmed by TURB and biopsy) For patients with pure CIS of the bladder no repeat TURB is necessary.

• Negative cytology before start of treatment, except for patients with concomitant CIS.

• Planned treatment starts 2-5 weeks after last TURB

• Pathological grading includes reporting according to WHO 1973 and 2004.

• One previous cycle of intravesical BCG (induction phase with at least 5 instillations ± maintenance) not more than 5 years ago for NMIBC.

• Patients have recurrent high-risk NMIBC for progression.

Exclusion Criteria:

• Current or previous ≥ T2 urothelial carcinoma (UC) of the urinary bladder

• Bladder surgery or traumatic catheterization or TURB within 2 weeks prior to the expected start of trial treatment

• Stress urinary incontinence >I°, severe urge or urge urinary incontinence preventing the patient to keep the IMP in the bladder for at least 1 hour. Residual urinary bladder volume after micturition is > 150 ml.

• Active concomitant malignant conditions except low risk prostate cancer qualifying for active surveillance according to PRIAS criteria (http://www.prostatecancer-riskcalculator.com/active-surveillance-and-prias-study), basal cell skin carcinoma and cervical carcinoma in situ. History of malignancy in the last 3 years except previous NMIBC.

• Primary or secondary immunodeficiencies

• Positive HIV test

• Chronic administration (defined as more than 14 consecutive days) of immunosuppressive drugs or other immune modifying drugs within three months before instillation

• Uncontrollable urinary tract infection, macroscopic haematuria, suspicion of bladder perforation, urethral strictures (if interfering with trial procedures)

• Current and past pelvic radiation and brachytherapy

• Active tuberculosis or other ongoing mycobacterial infection.

• History of anaphylaxis or severe allergic reactions, known allergies to any component of the investigational product, BCG intolerance

• Local and severe allergy (e.g. ulceration, systemic reactions) to PPD test

• Acute fever or fever (>38.5˚C) in the last 7 days before registration

• Simultaneous administration of antituberculous agents and antibiotics that cannot be stopped until registration