Study of Sacituzumab Govitecan in Participants with Urothelial Cancer
Research type
Research Study
Full title
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
IRAS ID
1005620
Contact name
Mitch Sierecki
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2018-001167-23
Clinicaltrials.gov Identifier
Research summary
This is a phase 2 open label study for metastatic urothelial cancer (mUC) to determine whether treatment with sacituzumab govitecan (SG) alone and in combination with other treatments namely cisplatin, zimberelimab (ZIM), domvanalimab (DOM), carboplatin (CARBO), gemcitabine (GEM) or avelumab improves tumour shrinkage and, if so, how long tumour shrinkage lasts in participants who may or may not have already received therapy. Current therapies are very limited and have poor efficacy and survival timelines (<12 months ). Highlighting the clear unmet medical need for new therapies for mUC.
The study will also test how the body processes the study medication. This process is called pharmacokinetics, or PK. Additional tests will be done to explore if the study medication affects certain functions in the body such as the electrical activity in the heart.
This study will be done at ~ 120 sites worldwide. Approx. 643 male or female participants (ppts), 18 years and older, will be enrolled in the study. The treatment duration will be, in general, 6 months ; however, ppts who continue to do well and tolerate the treatment will continue to receive treatment until their disease worsens or until the treatment causes any undesirable toxicities. After study treatment is over, all ppts will be followed up with a phone call (or visit) every 12 weeks for survival up to a maximum of 2 years.
This study will enrol 6 different groups but only groups 4-6 will enrol in the UK, based on the type of treatment they have already received for their cancer before entering the study. These ‘enrolment’ groups or cohorts will be divided into different treatment groups. Some of the treatment groups have different arms for further different medication combinations.
The ppts will be assessed during the study using CT/MRI scans, blood and urine samples as well as physical examinations and vital sign monitoring.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0273
Date of REC Opinion
30 Mar 2023
REC opinion
Further Information Favourable Opinion