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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06486441
Registration number
NCT06486441
Ethics application status
Date submitted
27/06/2024
Date registered
3/07/2024
Date last updated
25/06/2025
Titles & IDs
Public title
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
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Scientific title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
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Secondary ID [1]
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2024-511957-23
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Secondary ID [2]
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GS-US-682-6769
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Universal Trial Number (UTN)
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Trial acronym
ASCENT-GYN-01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab govitecan-hziy
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Paclitaxel
Experimental: Sacituzumab Govitecan (SG) - Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Active comparator: Treatment of Physician's Choice (TPC) - Participants will receive one of the following TPC, regimens determined prior to randomization.
* Doxorubicin 60 mg/m\^2 IV on Day 1 of a 21-day cycle
* Paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of a 28-day cycle
Treatment: Drugs: Sacituzumab govitecan-hziy
Administered intravenously
Treatment: Drugs: Doxorubicin
Administered intravenously
Treatment: Drugs: Paclitaxel
Administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 27 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival (OS) is defined as time from the date of randomization until death due to any cause.
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Timepoint [2]
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Up to approximately 47 months
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Secondary outcome [1]
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Objective Response Rate (ORR) as Assessed by BICR
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 47 months
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Secondary outcome [2]
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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
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline, Week 13
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Secondary outcome [3]
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PFS as Assessed by Investigator
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Assessment method [3]
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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
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Timepoint [3]
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Up to approximately 27 months
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Secondary outcome [4]
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ORR as Assessed by Investigator
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Assessment method [4]
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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
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Timepoint [4]
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Up to approximately 47 months
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Secondary outcome [5]
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Duration of Response (DOR) as Assessed by BICR and Investigator
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 47 months
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Secondary outcome [6]
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Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator
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Assessment method [6]
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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.
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Timepoint [6]
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Up to approximately 47 months
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Secondary outcome [7]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [7]
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Timepoint [7]
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First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
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Secondary outcome [8]
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Percentage of Participants Experiencing Clinical Laboratory Abnormalities
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Assessment method [8]
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Timepoint [8]
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First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
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Secondary outcome [9]
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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
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Assessment method [9]
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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).
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Timepoint [9]
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Baseline, Week 13
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/08/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2029
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Actual
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Sample size
Target
520
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Mater Cancer Care Centre - South Brisbane
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Monash Health - Clayton
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Peter MacCallum Cancer Centre - Melbourne
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Sir Charles Gairdner Hospital - Murdoch
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2050 - Camperdown
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4101 - South Brisbane
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3168 - Clayton
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3000 - Melbourne
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6150 - Murdoch
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Spain
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Barcelona
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Spain
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Jaén
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Palma
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Country [115]
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Spain
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Sabadell
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Spain
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San Sebastián
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
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Cambridge
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Northwood
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Other collaborator category [1]
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Other
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GOG Foundation
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Other
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Other
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Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
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Ethics approval
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06486441
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for public queries
Name
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Gilead Clinical Study Information Center
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Phone
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1-833-445-3230 (GILEAD-0)
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Email
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[email protected]
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06486441
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