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)

Gilead Sciences

Status and phase: Enrolling; Phase 3

Conditions: Endometrial Cancer

Treatments: Drug: Paclitaxel; Drug: Sacituzumab govitecan-hziy; Drug: Doxorubicin

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT06486441

2024-511957-23 (Other Identifier)

GS-US-682-6769

GOG-3104 (Other Identifier)

ENGOT-en26 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 520 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

Sacituzumab Govitecan (SG)

Experimental group

Description:

Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.

Treatment:

Drug: Sacituzumab govitecan-hziy

Treatment of Physician's Choice (TPC)

Active Comparator group

Description:

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:

Drug: Doxorubicin

Drug: Paclitaxel