Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
710
4 mg/kg of sacituzumab tirumotecan by IV infusion
60 mg/m\^2 of doxorubicin by IV Infusion
80 mg/m\^2 of paclitaxel by IV infusion
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Time frame: Up to approximately 4 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 4 years
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR.
Time frame: Up to approximately 4 years
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 4 years
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention.
Time frame: Up to approximately 4 years
Number of Participants Who Discontinue Study Intervention Due to an AE
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100 mg/m\^2 of nab-paclitaxel by IV infusion
USA Mitchell Cancer Institute ( Site 4142)
Mobile, Alabama, United States
Alaska Womens Cancer Care ( Site 4122)
Anchorage, Alaska, United States
HonorHealth (HH) ( Site 8000)
Phoenix, Arizona, United States
Arizona Oncology Associates - HOPE ( Site 8002)
Tucson, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
Los Angeles, California, United States
California Pacific Medical Center - Van Ness Campus ( Site 4129)
San Francisco, California, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
New Haven, Connecticut, United States
MedStar Washington Hospital Center ( Site 4108)
Washington D.C., District of Columbia, United States
Mount Sinai Cancer Center ( Site 4117)
Miami Beach, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
Orlando, Florida, United States
...and 231 more locations
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention.
Time frame: Up to approximately 4 years
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30])
The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions, "How would you rate your overall health during the past week (Item 29)?" and "How would you rate your overall quality of life during the past week (Item 30)?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Time frame: Baseline, up to approximately 4 years