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)

Purpose

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).

Condition

  • Endometrial Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Sacituzumab govitecan-hziy
    Administered intravenously
    Other names:
    • Trodelvy™
    • GS-0132
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
  • Drug: Doxorubicin
    Administered intravenously
    Other names:
    • Adriamycin
  • Drug: Paclitaxel
    Administered intravenously
    Other names:
    • Taxol

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com