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).
Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5, 6, and 7. Cohort 5 has been cancelled, effective December 2023.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
827
Administered intravenously.
Administered per package insert
Administered per package insert
Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on central review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)
PFS will be defined as the time from first dose until objective tumor progression, as assessed based on central review, or death, whichever comes first.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on investigator review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Overall Response Rate (ORR)
Gilead Clinical Study Information Center
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Administered per package insert
Administered intravenously
Administered per package insert
Administered per package insert
Administered intravenously
Administered intravenously
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
RECRUITINGUSC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
WITHDRAWNUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGRocky Mountain Cancer Centers
Littleton, Colorado, United States
RECRUITINGSmilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
RECRUITINGEastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
WITHDRAWNMount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
RECRUITINGWoodlands Medical Specialists, PA
Pensacola, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
COMPLETED...and 125 more locations
ORR will be defined as the rate of the best overall response as CR or PR and based on investigator review by RECIST 1.1 criteria for cohorts 3, 4, 6, and 7. ORR will also be evaluated based on investigator review by Modified RECIST 1.1 for Immune-Based Therapeutics (iRECIST 1.1) for Cohorts 3, 4, 6, and 7.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Duration of Response (DOR)
DOR will be calculated from the date of the first evaluation showing documented response, PR, or CR, to the date of the first disease progression or death and based on central and investigator review by RECIST 1.1 criteria for all cohorts. DOR will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose (Cohorts 1 through 4) or randomization date (Cohorts 5 through 7) until objective tumor progression,or death, whichever comes first and based on central and investigator review by RECIST 1.1 criteria for all cohorts. PFS will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Overall Survival (OS)
OS will be measured from the date of first dose (Cohorts 1 through 4) or randomization date (Cohorts 5 through 7) to death from any cause.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Clinical Benefit Rate (CBR)
CBR is defined as CR + PR + Stable Disease (SD) for at least 6 months and based on central and investigator review by RECIST 1.1 criteria for Cohorts 3, 4, 6, and 7. CBR will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohorts 3, 4, 5, and 6)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohorts 3, 4, 5, and 6)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)