At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sacituzumab Govitecan-hziy (drug), Pembrolizumab (drug), Cisplatin (drug), Avelumab (drug)
- How long the study runs
- Study runs about 140 months (dates as stated)
- About the drug or intervention
- Sacituzumab Govitecan-hziy — drug: Administered intravenously. · Pembrolizumab — drug: Administered per package insert · Cisplatin — drug: Administered per package insert · Avelumab — drug: Administered per package insert · Zimberelimab — drug: Administered intravenously · Carboplatin — drug: Administered per package insert · Gemcitabine — drug: Administered per package insert · Domvanalimab — drug: Administered intravenously · Enfortumab Vedotin — drug: Administered intravenously
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a drug called sacituzumab govitecan for people with urothelial cancer (a cancer of the bladder and urinary system) that cannot be removed by surgery or has spread to other parts of the body. The study is run by Gilead Sciences and has several groups, called cohorts, each with slightly different requirements.
Who can take part
- Adults aged 18 or over (19 or over in South Korea), female or male
- Generally fit and well enough for everyday activity (performance status score of 0 or 1)
- Healthy enough kidneys, liver, and blood counts, without needing transfusions
- Expected to live at least 3 more months
- Most groups require cancer that has come back or got worse after platinum chemotherapy (such as cisplatin or carboplatin) and/or immunotherapy drugs called anti-PD-1 or anti-PD-L1 treatments
- Some groups need a sample of tumour tissue (from stored tissue or a biopsy) and tumours that can be measured on a CT or MRI scan
Who may not be able to
- Women who are pregnant or breastfeeding
- Another active cancer, or an active infection with hepatitis B or hepatitis C
- Cancer that has spread to the brain or spinal cord, or carcinomatous meningitis
- Certain other ongoing medical or mental health conditions
- In some groups: past anti-PD-1/PD-L1 therapy, an active autoimmune disease treated in the last 2 years, a live vaccine in the last 30 days, or a history of lung disease such as interstitial lung disease
- In one group (cohort 7): recent anticancer treatment, radiation in the last 2 weeks, certain lung conditions, severe liver disease (Child-Pugh B or C), uncontrolled diabetes, eye problems such as keratitis or corneal ulcers, or ongoing numbness/weakness in nerves
What taking part involves
- • Not stated — ask the trial team. The study drug is sacituzumab govitecan, but details of how it is given, and whether other drugs are included, are not stated in this data.
Time commitment: Not stated — ask the trial team; details such as how long the study lasts, how often visits happen, and what tests are needed are not stated in this data.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 502
- Started
- 2018-08-13
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic urothelial cancer
- • Phase2 - 502 participants
- • The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic urothelial cancer
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • London - Barts Health NHS Trust
- • Northwood - East and North Hertfordshire NHS Trust
- • Surrey - The Royal Marsden NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
More detail
Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5, 6, and 7. Cohort 5 has been cancelled, effective December 2023.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a 3-month life expectancy
What the study is looking for
- ✓Inclusion Criteria for All Cohorts:
- ✓Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
- ✓activity scale (ECOG) Performance status score of 0 or 1.
- ✓Adequate kidney and liver function.
- ✓Adequate blood parameters without transfusional support.
Who cannot take part
- ✗Exclusion Criteria for All cohorts:
- ✗Females who are pregnant or lactating.
- ✗Has an active second cancer.
- ✗Has known active Hepatitis B or Hepatitis C.
- ✗Has other concurrent medical or psychiatric conditions.
See the full criteria
Where Is This Study? (4 UK sites)
University Hospitals Birmingham NHS Foundation Trust
Birmingham B9 5SS, United Kingdom
Barts Health NHS Trust
London E1 1BB, United Kingdom
East and North Hertfordshire NHS Trust
Northwood HA6 2JW, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069The Royal Marsden NHS Foundation Trust
Surrey SM2 5PT, United Kingdom
