Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Trial acronym
ASCENT-GYN-01
Clinical summary
Summary
The goal of this clinical study is to find out how well the study drug, called sacituzumab govitecan, works compared to treatment of physician's choice in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and anti PD-1/PD-L1 immunotherapy.
Sacituzumab govitecan is an antibody-drug conjugate (ADC) that targets and binds to a protein called Trop-2 on cancer cells, and then delivers chemotherapy directly to the cell.
Eligible participants will be randomly allocated (bychance) to one of two treatment arms.
In the Experimental Arm, participants will receive Sacituzumab govitecan intravenously on Days 1 and 8 of a 21-day cycle.
In the Active Comprator Arm, participants will receive one of the following treatment regimens of physician's choice:
- Doxorubicin chemotherapy, intravenously on Day 1 of a 21-day cycle, or
- Paclitaxel chemotherapy, intravenously on Days 1, 8 and 15 of a 28-day cycle.
Conditions
This trial is treating people with recurrent or persistent endometrial cancer
Eligibility
Inclusion
- 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
Exclusion
- 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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT06486441 *
- GS-US-682-6769; 2024-511957-23; GOG-3104; ENGOT-EN26
Trial sponsor
Gilead Sciences
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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