Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy
NCT Number: NCT06486441
Acronym: ASCENT-GYN-01
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Endometrial Cancer
Interventions: DRUG: Sacituzumab govitecan-hziy|DRUG: Doxorubicin|DRUG: Paclitaxel
Sponsor: Gilead Sciences
Collaborators: GOG Foundation|European Network of Gynaecological Oncological Trial Groups (ENGOT)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-06

Summary:
The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC).

The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).

Primary Outcome Measures: Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR), PFS, defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever comes first., Up to approximately 27 months|Overall Survival (OS), Overall survival (OS) is defined as time from the date of randomization until death due to any cause., Up to approximately 47 months
Secondary Outcome Measures: Objective Response Rate (ORR) as Assessed by BICR, ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1., Up to approximately 47 months|Change from Baseline in the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 13, The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. The physical functioning scale range in score from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant)., Baseline, Week 13|PFS as Assessed by Investigator, PFS is defined as the time from the date of randomization until the date of objective PD, as assessed by investigator per RECIST v1.1, or death from any cause, whichever comes first, Up to approximately 27 months|ORR as Assessed by Investigator, ORR is defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1, Up to approximately 47 months|Duration of Response (DOR) as Assessed by BICR and Investigator, DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD as assessed by BICR and investigator per RECIST v1.1, or death from any cause, whichever comes first., Up to approximately 47 months|Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator, CBR is defined as the percentage of participants with best overall response of CR or PR that is confirmed ≥ 4 weeks after initial documentation of response or durable stable disease (SD; duration of SD ≥ 6 months from randomization to disease progression), as assessed by BICR and investigator per RECIST v1.1., Up to approximately 47 months|Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), First dose date up to 30 days post last dose (Up to Up to approximately 47 months)|Percentage of Participants Experiencing Clinical Laboratory Abnormalities, First dose date up to 30 days post last dose (Up to Up to approximately 47 months)|Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 13, The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. Global health status score ranges from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant)., Baseline, Week 13