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New treatment option for Metastatic Urothelial Cancer
Official title Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
ClinicalTrials.gov ID: NCT03547973
What this study is testing
What is Sacituzumab Govitecan-hziy?
Sacituzumab Govitecan-hziy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic urothelial cancer.
Also referred to as IMMU-132, Trodelvy™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 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.
You likely can't join if
- 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)...
- Has an active second malignancy.
- Has known active Hepatitis B or Hepatitis C.
- Has other concurrent medical or psychiatric conditions.
See the full eligibility criteria
Who can join
- Key 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 for Cohorts 1 to 6:
- Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
- Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
- 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...
- 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...
- 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...
- 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...
- 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 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Littleton, Colorado, United States
- New Haven, Connecticut, United States
- Norwich, Connecticut, United States
- Miami Beach, Florida, United States
- Pensacola, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Brandywine, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Omaha, Nebraska, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
+ 95 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Littleton, Colorado, United States; New Haven, Connecticut, United States; Norwich, Connecticut, United States and 109 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.