Clinical trial NCT06486441: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometrial Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
First posted: 2024-07-03
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 27 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 47 months
Secondary outcomes:
measure: Objective Response Rate (ORR) as Assessed by BICR
timeFrame: Up to approximately 47 months
measure: 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
timeFrame: Baseline, Week 13
measure: PFS as Assessed by Investigator
timeFrame: Up to approximately 27 months
measure: ORR as Assessed by Investigator
timeFrame: Up to approximately 47 months
measure: Duration of Response (DOR) as Assessed by BICR and Investigator
timeFrame: Up to approximately 47 months
measure: Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator
timeFrame: Up to approximately 47 months
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
measure: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
timeFrame: First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
measure: 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
timeFrame: Baseline, Week 13
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Women's Cancer Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
state: Colorado
city: Hartford
country: United States
facility: Hartford HealthCare Cancer Institute at Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital (Cancer Institute)
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Covington
country: United States
facility: Women's Cancer Care
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium (MMCORC)
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, Herbert Irving Pavilion
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Horsham
country: United States
facility: Alliance Cancer Specialists, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System, Perelman Center for Advanced Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Comprehensive Cancer Center
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin (MCW)
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Itajai
country: Brazil
facility: Clínica de Neoplasias Litoral
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
city: Quebec
country: Canada
facility: CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Second Hospital of Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Guangxi Zhuang Autonomous Region
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan City
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Nový Jičín
country: Czechia
facility: Nemocnice AGEL, Nový Jičín a.s.
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Prague
country: Czechia
facility: University Hospital Bulovka
city: Caen Cedex 5
country: France
facility: Centre Francois Baclesse
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Cochin
city: Pierre Benite
country: France
facility: HCL - Centre Hospitalier Lyon Sud
city: Saint-Herblain
country: France
facility: ICO - Centre René Gauducheau
city: Vandoeuvre Les Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Bad Homburg
country: Germany
facility: Hochtaunus Kliniken Bad Homburg
city: Düsseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Essen
country: Germany
facility: University Hospital Essen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Hannover
country: Germany
facility: Medical School Hannover
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Athens
country: Greece
facility: Aretaeion Hospital
city: Patras
country: Greece
facility: General Hospital of Patras Agios Andreas
city: Thessaloniki
country: Greece
facility: St. Luke's Hospital
city: Happy Valley
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: ramat GAn
country: Israel
facility: Sheba Medical Center
city: Tel Aviv-Yaffo
country: Israel
facility: Sourasky T.A.M.C.
city: Aviano
country: Italy
facility: SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica
city: Lecco
country: Italy
facility: ASST Lecco - Ospedale Alessandro Manzoni
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
city: Milan
country: Italy
facility: Irccs Ospedale San Raffaele-UO Ginecologia
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano di Torino
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: The Jikei University Kashiwa Hospital
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Kanagawa
country: Japan
facility: St. Marianna University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital Of JFCR
city: Dalseo-gu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center - Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne SUM
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Jaén
country: Spain
facility: Hospital Universitario Ciudad de Jaen
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe - Valencia
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
city: London
country: United Kingdom
facility: University College London Hospitals
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: