Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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)
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
Secondary ID [1] 0 0
2024-511957-23
Secondary ID [2] 0 0
GS-US-682-6769
Universal Trial Number (UTN)
Trial acronym
ASCENT-GYN-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 27 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 47 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by BICR
Timepoint [1] 0 0
Up to approximately 47 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline, Week 13
Secondary outcome [3] 0 0
PFS as Assessed by Investigator
Timepoint [3] 0 0
Up to approximately 27 months
Secondary outcome [4] 0 0
ORR as Assessed by Investigator
Timepoint [4] 0 0
Up to approximately 47 months
Secondary outcome [5] 0 0
Duration of Response (DOR) as Assessed by BICR and Investigator
Timepoint [5] 0 0
Up to approximately 47 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator
Timepoint [6] 0 0
Up to approximately 47 months
Secondary outcome [7] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [7] 0 0
First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
Secondary outcome [8] 0 0
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timepoint [8] 0 0
First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 13

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2029
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
Changchun
Country [26] 0 0
China
State/province [26] 0 0
Chongqing
Country [27] 0 0
China
State/province [27] 0 0
Nanchang
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Wuhan City
Country [30] 0 0
China
State/province [30] 0 0
Wuhan
Country [31] 0 0
China
State/province [31] 0 0
Xi'an
Country [32] 0 0
France
State/province [32] 0 0
Nice
Country [33] 0 0
France
State/province [33] 0 0
Pierre Benite
Country [34] 0 0
Germany
State/province [34] 0 0
Essen
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Hong Kong
Country [36] 0 0
Hong Kong
State/province [36] 0 0
New Territories
Country [37] 0 0
Italy
State/province [37] 0 0
Aviano
Country [38] 0 0
Italy
State/province [38] 0 0
Firenze
Country [39] 0 0
Italy
State/province [39] 0 0
Meldola
Country [40] 0 0
Italy
State/province [40] 0 0
Milan
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Italy
State/province [42] 0 0
Torino
Country [43] 0 0
Japan
State/province [43] 0 0
Chiba
Country [44] 0 0
Japan
State/province [44] 0 0
Hyogo
Country [45] 0 0
Japan
State/province [45] 0 0
Mie
Country [46] 0 0
Japan
State/province [46] 0 0
Okayama
Country [47] 0 0
Japan
State/province [47] 0 0
Tokyo
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Dalseo-gu
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Goyang-si
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Poland
State/province [51] 0 0
Gdynia
Country [52] 0 0
Poland
State/province [52] 0 0
Siedlce
Country [53] 0 0
Singapore
State/province [53] 0 0
Singapore
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Tainan
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taoyuan City
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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