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

Description
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

Objective
Primary:
- To compare the effect of sacituzumab govitecan (SG) relative to treatment of physician s choice (TPC) on progression-free survival (PFS) as assessed by blinded independent central review (BICR)
- To compare the effect of SG relative to TPC on OS

Secondary:
- To compare the effect of SG relative to TPC on objective response rate as assessed by BICR
- To compare the effect of SG relative to TPC on physical function
- To compare the effect of SG relative to TPC on the following:
? PFS as assessed by investigator
? ORR as assessed by investigator
? Duration of response (DOR) as assessed by
BICR and investigator
? Clinical benefit rate (CBR) as assessed by BICR
and investigator
- To evaluate the safety and tolerability of SG relative to TPC
- To compare the effect of SG relative to TPC on Global Health Status/ QoL

Treatment 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).

Key Eligibility 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

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.

Applicable Disease Sites
Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital