NCT03421236

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

Status unknown Phase 1 Last updated 28 April 2021

What this trial tests

Phase 1 trial testing Ty21a in Non Muscle Invasive Bladder Cancer in 25 participants. Status unknown.

Timeline

18 February 2018

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	Patrice Jichlinski
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	18 February 2018
Primary completion	1 December 2021
Estimated completion	1 December 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Ty21a — full drug profile →

Conditions studied

• Non Muscle Invasive Bladder Cancer — all drugs for Non Muscle Invasive Bladder Cancer →

Sponsor

Patrice Jichlinski — full company profile →

Who can join

18 and older, any sex, with Non Muscle Invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update.
   Guallar-Garrido S, Julián E. · · 2020 · cited 138× · PMID 32104666 · DOI 10.2147/itt.s202006
2. Repurposing Infectious Diseases Vaccines Against Cancer.
   Vandeborne L, Pantziarka P, Van Nuffel AMT, Bouche G. · · 2021 · cited 21× · PMID 34055652 · DOI 10.3389/fonc.2021.688755
3. Intravesical Therapy for Non-muscle Invasive Bladder Cancer-Current and Future Options in the Age of Bacillus Calmette-Guerin Shortage.
   Golla V, Lenis AT, Faiena I, Chamie K. · · 2019 · cited 17× · PMID 32071562
4. New Roadmaps for Non-muscle-invasive Bladder Cancer With Unfavorable Prognosis.
   Pane K, Mirabelli P, Coppola L, Illiano E, et al · · 2020 · cited 11× · PMID 32850635 · DOI 10.3389/fchem.2020.00600
5. Bacteria-Based Nanoprobes for Cancer Therapy.
   Lu Y, Mei N, Ying Y, Wang D, et al · · 2024 · cited 8× · PMID 38283198 · DOI 10.2147/ijn.s438164
6. Phase I neoadjuvant study of intravesical recombinant fowlpox-GM-CSF (rF-GM-CSF) or fowlpox-TRICOM (rF-TRICOM) in patients with bladder carcinoma.
   Portal DE, Weiss RE, Wojtowicz M, Mansour A, et al · · 2020 · cited 7× · PMID 31222182 · DOI 10.1038/s41417-019-0112-z
7. Intravesical Ty21a Treatment of Non-muscle-invasive Bladder Cancer Shows a Good Safety Profile.
   Lucca I, Derré L, Cesson V, Bohner P, et al · · 2022 · cited 6× · PMID 36212980 · DOI 10.1016/j.euros.2022.09.004
8. Role of immunotherapy in Bacillus Calmette-Guérin unresponsive: non-muscle invasive bladder cancer.
   Suh J, Yoo S. · · 2020 · cited 6× · PMID 35117263 · DOI 10.21037/tcr-20-758