The objective of the trial is to determine safety, tolerability and efficacy of VPM1002BC, in order to establish this medication as a therapy for non-muscle invasive bladder cancer in the future.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase I: Dose limiting toxicity of intravesical VPM1002BC instillations
Phase II: Recurrence-free rate in the bladder at 60 weeks
Secondary outcome
Time to recurrence in the bladder
Time to recurrence
Time to progression
Overall survival
Adverse events
Tolerability
Quality of Life
Background summary
For patients with recurrence of a non-muscle invasive bladder cancer after BCG
therapy, the current guidelines recommend cystectomy as the oncologically
safest therapy option, and a second course of BCG therapy as a possibility for
bladder sparing. Whilst for the bladder sparing therapy, retrospective studies
describe a response to second BCG therapy in up to 50 % of patients, recent
prospective studies show significantly poorer responses. There are only few
therapy options for patients not willing to have cystectomy or not fit enough
for the operation. With the genetically modified VPM1002BC, an innovative
immunotherapy with very good immunogenicity and safety in preclinical studies
is offered to this group of patients.
Study objective
The objective of the trial is to determine safety, tolerability and efficacy of
VPM1002BC, in order to establish this medication as a therapy for non-muscle
invasive bladder cancer in the future.
Study design
Multicenter, open label, single arm, phase I/II trial
Intervention
Induction: 6 intravesical instillations of VPM1002BC in 6-12 weeks
Maintenance: 3 instillations of VPM1002BC at months 3, 6 and 12
Study burden and risks
In view of the documented risks, and in view of the overall potential benefit
for patients suffering from recurrent NMIBC, the benefit-risk-balance for this
study is considered to be acceptable. The identified risks associated with
VPM1002BC treatment are the one expected in conventional BCG treatment but in
milder form such as infection and infestation (cystitis and inflammatory
reaction), fever, flu-like symptoms including malaise, fever, chills, general
discomfort, nausea, frequent urination with discomfort and pain and in man
asymptomatic granulomatous prostatitis. Some adverse events can be anticipated
so that a mitigation of the risks can be performed.
Of note, based on the recombinant and less virulent nature of VPM1002BC as
compared to routine BCG strains, the sponsor anticipates a considerably
improved safety profile, a factor of key importance in settings with elderly
patients, for whom a chemotherapy is normally not indicated due to other
co-morbidities and high anesthesiological risk.
Effingerstrasse 33
Bern CH- 3008
CH
Effingerstrasse 33
Bern CH- 3008
CH
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-005330-58-NL |
| ClinicalTrials.gov | NCT02371447 |
| CCMO | NL58065.000.16 |