Phase
Condition
Bladder Cancer
Urothelial Cancer
Treatment
Rescue medication
Supportive care measures
Sacituzumab tirumotecan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in thebladder
Must have visible tumor by cystoscopy within 12 weeks prior to first dose
Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:
Multiple tumors
>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis atScreening
Early recurrence (<1 year) of the initial diagnosis of low-grade disease
Solitary tumor >3 cm
Failure of prior intravesical treatment
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessedwithin 14 days prior to first dose
Exclusion
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in thebladder
Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasivebladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
Has history of documented severe dry eye syndrome, severe Meibomian gland disease,and/or blepharitis, or severe corneal disease that prevents and/or delays cornealhealing
Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease (eg, Chron's disease, ulcerativecolitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Known additional malignancy that is progressing or has required active treatmentwithin the past 3 years
History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.
Study Design
Connect with a study center
Princess Margaret Cancer Centre ( Site 0003)
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Princess Margaret Cancer Centre ( Site 0003)
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
CIUSSS de l'Estrie-CHUS ( Site 0002)
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
CIUSSS de l'Estrie-CHUS ( Site 0002)
Sherbrooke 6146143, Quebec 6115047 J1H 5N4
CanadaSite Not Available
Hôpital Claude Huriez ( Site 0012)
Lille, Nord 59037
FranceActive - Recruiting
Hôpital Claude Huriez ( Site 0012)
Lille 2998324, Nord 59037
FranceSite Not Available
HENRI MONDOR HOSPITAL ( Site 0011)
Creteil, Val-de-Marne 94010
FranceSite Not Available
HENRI MONDOR HOSPITAL ( Site 0011)
Créteil, Val-de-Marne 94010
FranceActive - Recruiting
HENRI MONDOR HOSPITAL ( Site 0011)
Créteil 3022530, Val-de-Marne 94010
FranceSite Not Available
Gustave Roussy ( Site 0013)
Villejuif, Val-de-Marne 94805
FranceActive - Recruiting
Gustave Roussy ( Site 0013)
Villejuif 2968705, Val-de-Marne 94805
FranceSite Not Available
Erasmus Medisch Centrum ( Site 0032)
Rotterdam, South Holland 3015 GD
NetherlandsActive - Recruiting
Erasmus Medisch Centrum ( Site 0032)
Rotterdam 2747891, South Holland 2743698 3015 GD
NetherlandsSite Not Available
Hospital Universitario Virgen de la Victoria ( Site 0043)
Malaga, Andalucia 29010
SpainSite Not Available
Hospital Universitario Virgen de la Victoria ( Site 0043)
Málaga, Andalusia 29010
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria ( Site 0043)
Málaga 2514256, Andalusia 2593109 29010
SpainSite Not Available
Hospital Universitario 12 de Octubre ( Site 0042)
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario 12 de Octubre ( Site 0042)
Madrid 3117735, 28041
SpainSite Not Available
St Bartholomew s Hospital ( Site 0061)
London, London, City of EC1A 7BE
United KingdomActive - Recruiting
St Bartholomew s Hospital ( Site 0061)
London 2643743, London, City of EC1A 7BE
United KingdomSite Not Available
Michael G Oefelein Clinical Trials ( Site 0053)
Bakersfield, California 93301
United StatesActive - Recruiting
Michael G Oefelein Clinical Trials ( Site 0053)
Bakersfield 5325738, California 5332921 93301
United StatesSite Not Available
Moffitt Cancer Center ( Site 0057)
Tampa, Florida 33612
United StatesActive - Recruiting
Moffitt Cancer Center ( Site 0057)
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Northwestern University ( Site 0051)
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern University ( Site 0051)
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Johns Hopkins University ( Site 0055)
Baltimore, Maryland 21287
United StatesActive - Recruiting
Johns Hopkins University ( Site 0055)
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available

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