Gilead/GOG, GS-US-682-6769/GOG-3104, Ph 3, open,Sacituzumab Govitecan vs TPC,Endometrial CA

What is the Purpose of this Study?

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 overall survival (OS) Secondary 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 (GHS)/quality of life (QoL)


Eligibility

  • * 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.
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Garrett Crook

More about this Clinical Trial

What is the full name of this clinical trial?

GS-US-682-6769/GOG-3104: 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

Study Details
Disease Type/Condition

Other Female Genital

Principal Investigator

Liang, Margaret

Co-Investigators

Andrew Li, Bobbie Jo Rimel

Age Group

Adult

Phase

III

IRB Number

STUDY00003871

ClinicalTrials.gov ID

NCT06486441

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Garrett Crook

Email
Garrett.Crook@cshs.org
Study Detail
Disease Type/Condition

Other Female Genital

Principal Investigator

Liang, Margaret

Age Group

Adult

Phase

III

IRB Number

GS-US-682-6769/GOG-3104

ClinicalTrials.gov ID

NCT06486441

Key Eligibility
ClinicalTrials.gov

Contact
Name

Garrett Crook

Email
Garrett.Crook@cshs.org