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Trial 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)
NCT ID:
NCT06486441
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Doxorubicin
Sacituzumab govitecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab govitecan-hziy
Description:
Administered intravenously
Arm group label:
Sacituzumab Govitecan (SG)
Other name:
Trodelvy™
Other name:
GS-0132
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Administered intravenously
Arm group label:
Treatment of Physician's Choice (TPC)
Other name:
Adriamycin
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Administered intravenously
Arm group label:
Treatment of Physician's Choice (TPC)
Other name:
Taxol
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).
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University School of Medicine
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists MAIN
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Facility:
Name:
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Health Lexington
Address:
City:
Lexington
Zip:
40503
Country:
United States
Status:
Recruiting
Facility:
Name:
Women's Cancer Care
Address:
City:
Covington
Zip:
70433
Country:
United States
Status:
Recruiting
Facility:
Name:
West Michigan Cancer Center
Address:
City:
Kalamazoo
Zip:
49007
Country:
United States
Status:
Recruiting
Facility:
Name:
MMCORC
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Recruiting
Facility:
Name:
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Address:
City:
Tulsa
Zip:
74146
Country:
United States
Status:
Recruiting
Facility:
Name:
Alliance Cancer Specialists, PC
Address:
City:
Horsham
Zip:
19044
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Start date:
August 28, 2024
Completion date:
June 2029
Lead sponsor:
Agency:
Gilead Sciences
Agency class:
Industry
Collaborator:
Agency:
GOG Foundation
Agency class:
Other
Collaborator:
Agency:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Agency class:
Other
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06486441
https://www.gileadclinicaltrials.com/study?nctid=NCT06486441
