Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03421236|
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non Muscle Invasive Bladder Cancer||Biological: Ty21a||Phase 1|
Escalating doses of Ty21a/Vivotif® will be administered by the intravesical route to evaluate whether Ty21 may replace the standard BCG immunotherapy in NMIBC patients.
The minimal starting dose will be instilled intravesically once a week for 4 weeks in 3 patients. If well tolerated, a 5-fold higher dose will be instilled 4-times in 3 other patients, and so on for a maximum of 4 doses to be tested.
The maximal tolerated dose will then be administered to 3 new patients 6-times once a week. If 6 instillations are well tolerated, 7 additional patients will be included to receive 6 instillations with this maximal tolerated dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)|
|Actual Study Start Date :||February 18, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: non muscle invasive bladder cancer patient
intravesical instillation of Ty21a in patients not requiring BCG
intravesical administration of Ty21a
- Adverse events [ Time Frame: 6 weeks ]safety and tolerability of intravesical Ty21a
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421236
|Contact: denise N Haefliger, PhDfirstname.lastname@example.org|
|Contact: Denise N Haefliger, PhDemail@example.com|
|Dpt Urology- CHUV||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: denise N Haefliger 213144081 firstname.lastname@example.org|