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ACTIVE NOT RECRUITINGPhase2

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

Sponsor: Gilead Sciences

NCT ID: NCT03547973

View on ClinicalTrials.gov ↗

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.

Metastatic Urothelial Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

PD-L1PR

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
Key Inclusion Criteria: Inclusion Criteria for All Cohorts: * Female or male individuals, ≥ 18 years of age (19 Years old for South Korea). * Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1. * Adequate renal and hepatic function. * Adequate hematologic parameters without transfusional support. * Individuals must have a 3-month life expectancy. Additional Inclusion Criteria for Cohorts 1 to 6: * Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin): 1. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease; 2. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy. * Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy. * Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease. * Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy. * Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg/m\^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m\^2 Day 1 and Day 8 of every 21-day cycle). * Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma. * Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \> 12 months from completion of therapy. * No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator). * Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy. * Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or \>12 months from completion of adjuvant therapy are permitted. * Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified Additional Inclusion Criteria for Cohort 7: * No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \> 12 months since the last dose of systemic therapy. * Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma. * Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Key Exclusion Criteria: Exclusion Criteria for All cohorts: * Females who are pregnant or lactating. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has an active second malignancy. * Has known active Hepatitis B or Hepatitis C. * Has other concurrent medical or psychiatric conditions. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has an active second malignancy. Additional Exclusion Criteria for Cohorts 1 to 6: * For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade \<\< 2 adverse events not constituting a safety risk based on the investigator's judgment are acceptable. * Cohort 3: Has received anti-PD-1/PD-L1 therapy previously. * Cohorts 3 to 6: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose of study drug(s), has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis. * Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant/adjuvant setting. * Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free interval \>12 months between the last treatment administration and the date of recurrence is required. Additional Exclusion Criteria for Cohort 7: * Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product. * Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Have a Child-Pugh score of B or C. * Individuals with uncontrolled diabetes. * Have active keratitis or corneal ulcerations. * Participants with ongoing sensory or motor neuropathy Grade ≥ 2. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where Is This Study? (4 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B9 5SS, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Barts Health NHS Trust

London E1 1BB, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

East and North Hertfordshire NHS Trust

Northwood HA6 2JW, United Kingdom

Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

The Royal Marsden NHS Foundation Trust

Surrey SM2 5PT, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416
Data sourced from ClinicalTrials.gov · Last verified: 2026-08