Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)

NCT03421236 | Unknown Phase 1

• 1 other identifier: IvesTy21a
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder cancer is the fourth and eighth most common malignancy among men and women, respectively. About 75% of bladder cancers are diagnosed as non muscle-invasive and according to specific tumor-stage and grade characteristics, intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) is used to prevent recurrence and/or progression. However, BCG immunotherapy is associated with significant adverse events and treatment failure may occur in 30-40% of cases, hence the necessity for alternative therapies. In an orthotopic MB49 mouse bladder cancer model, another bacterial vaccine (Ty21a/Vivotif) turned out to be more effective than BCG for inducing tumor regression and mice survival upon intravesical instillation; and potentially safer because Ty21a bacteria did not infect/persist in any mice tissues nor in human bladder explants or cell lines, in contrast to BCG. Ty21a/Vivotif has been used in the last 30 years in millions of individuals as an oral typhoid vaccine with a high safety record. In this phase I trial we will be testing the safety of intravesical administration of Ty21a and its effect on bladder immunity in non-muscle invasive bladder cancer (NMIBC) patients, for whom recommendation of BCG therapy is not mandatory.

Conditions

Non Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events

  safety and tolerability of intravesical Ty21a

  6 weeks

Study Arms (1)

non muscle invasive bladder cancer patient

EXPERIMENTAL

intravesical instillation of Ty21a in patients not requiring BCG

Biological: Ty21a

Interventions

Ty21a BIOLOGICAL

intravesical administration of Ty21a

non muscle invasive bladder cancer patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an intermediary or low risk of progression of bladder cancer (according to an EORTC score and clinical considerations) and thus not requiring BCG immunotherapy will be included after a transurethral resection of the bladder tumor (TURBT). Male and Female patients aged \> 18yrs, with a Karnofsky performance status of 60% or more, sero-negative for HIV, HBV and HCV and with laboratory parameters for vital function in the normal range or with abnormalities without clinical significance may be included.

You may not qualify if:

• Patients with NMIBC that require BCG treatments or with muscle-invasive bladder cancer, sero-positive for HIV, HBV and HCV or with other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders, autoimmune disease), will be excluded.

Sponsors & Collaborators

• Patrice Jichlinski: lead

Study Sites (1)

Dpt Urology- CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

• Lucca I, Derre L, Cesson V, Bohner P, Crettenand F, Rodrigues-Dias S, Dartiguenave F, Masnada A, Texeira-Pereira C, Benmerzoug S, Chevalier M, Domingos-Pereira S, Nguyen S, Polak L, Schneider A, Roth B, Jichlinski P, Nardelli-Haefliger D. Intravesical Ty21a Treatment of Non-muscle-invasive Bladder Cancer Shows a Good Safety Profile. Eur Urol Open Sci. 2022 Oct 3;45:55-58. doi: 10.1016/j.euros.2022.09.004. eCollection 2022 Nov.

  PMID: 36212980 DERIVED

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Ty21a typhoid vaccine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

denise N Haefliger, PhD

CONTACT

+41213144081; dnardell@hospvd.ch

Denise N Haefliger, PhD

CONTACT

0213144081; dnardell@hospvd.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Dpt Chief

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 18, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)