Endometrial Cancer
Conditions
Brief 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).
Interventions
DRUGSacituzumab govitecan-hziy
Administered intravenously
DRUGDoxorubicin
Administered intravenously
DRUGPaclitaxel
Administered intravenously
Sponsors
Gilead Sciences
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Asia-Pacific Gynecologic Oncology Trials Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma). * Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately. * Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator. * Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. * Adequate organ function Key
Exclusion criteria
* Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded. * Participants who are candidates for curative-intent therapy at the time of study enrollment. * Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator. * Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC). * Have an active second malignancy. * Have an active serious infection requiring systemic antimicrobial therapy. * Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization. * Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) | Up to approximately 27 months | 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. |
| Overall Survival (OS) | Up to approximately 47 months | Overall survival (OS) is defined as time from the date of randomization until death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by BICR | Up to approximately 47 months | 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. |
| 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 16 | Baseline, Week 16 | 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). |
| PFS as Assessed by Investigator | Up to approximately 27 months | 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 |
| ORR as Assessed by Investigator | Up to approximately 47 months | 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 |
| Duration of Response (DOR) as Assessed by BICR and Investigator | Up to approximately 47 months | 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. |
| Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator | Up to approximately 47 months | 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. |
| 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 16 | Baseline, Week 16 | 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). |
Countries
Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed