The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
711
Administered intravenously
Administered intravenously
Administered intravenously
Overall Survival (OS)
OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis.
Time frame: Up to 42 months
Progression-Free Survival (PFS) by Investigator Assessment
PFS was defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per response evaluation criteria in solid tumors (RECIST) v1.1 criteria as determined by investigator assessment, or death regardless of cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). KM estimates were used for analysis.
Time frame: Up to 42 months
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first. PD was defined in outcome measure (OM) #2. KM estimates were used for analysis.
Time frame: Up to 42 months
Objective Response Rate (ORR) by Investigator Assessment
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as best overall response (BOR) as assessed by investigator assessment. CR was defined as disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Percentages were rounded off.
Time frame: Up to 42 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered intravenously
Mayo Clinic - Arizona
Phoenix, Arizona, United States
UCLA Hematology/ Oncology
Los Angeles, California, United States
University of California Irvine (UCIMC)
Orange, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Boca Raton Clinical Research Global USA - Plantation
Plantation, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
...and 224 more locations
Objective Response Rate (ORR) by BICR
ORR was defined as the percentage of participants who achieved a CR or PR as BOR as assessed by BICR. CR and PR are defined in OM#4. Percentages were rounded off.
Time frame: Up to 42 months
Clinical Benefit Rate (CBR) by Investigator Assessment
CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or stable disease (SD) for ≥ 6 months, per RECIST v1.1, as assessed by investigator assessment. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; PD was defined in OM#2; BOR, CR and PR are defined in OM#4. Percentages were rounded off.
Time frame: Up to 42 months
Clinical Benefit Rate (CBR) by BICR
CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or SD for ≥ 6 months, per RECIST v1.1, as assessed by BICR. PD was defined in OM#2; BOR, CR and PR are defined in OM#4; SD was defined in OM#6. Percentages were rounded off.
Time frame: Up to 42 months
Duration of Objective Tumor Response (DOR) by Investigator Assessment
DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4.
Time frame: Up to 42 months
Duration of Objective Tumor Response (DOR) by BICR
DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4.
Time frame: Up to 42 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. The SAE was defined as any untoward medical occurrence that at any dose which was fatal (results in death) or life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or an important medical event. TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment. Percentages were rounded off.
Time frame: From first dose up to 33.6 months
Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities
A laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time of postbaseline up to and including the date of last study drug dose plus 30 days. Severity grades were defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death. Percentages were rounded off.
Time frame: From first dose up to 33.6 months
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life.
Time frame: Baseline (Day 0)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life.
Time frame: Cycle 5 Day 1; Cycle length = 21 days