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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
Overall Recruitment Status: Active, currently enrolling
 
Official 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
 
Region Sponsors
California - Northern
Gilead Sciences
 
Acronym NCT No.
ASCENT-GYN-01 NCT06486441
 
Study Type Phase
INTERVENTIONAL
Phase III
 
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).
 
Detailed Description
 
 
 
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.
 
Keywords and/or Specific Medical Conditions
  • Female
  • Neoplasms by Site
  • Female
  • Oncology (Adult)
  • Female Urogenital Diseases
  • Urogenital Diseases
  • Female Urogenital Diseases and Pregnancy Complications
  • Urogenital Neoplasms
  • Genital Diseases
  • Uterine Diseases
  • Genital Diseases
  • Uterine Neoplasms
  • Genital Neoplasms
  • Endometrial Neoplasms
  • Neoplasms
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Oakland Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Juraj   Kavecansky
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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