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NCT Number: NCT06486441

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)

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacituzumab Govitecan-hziy

Drug

Administered intravenously

Other names: Trodelvy™, GS-0132

Doxorubicin

Drug

Administered intravenously

Other names: Adriamycin

paclitaxel

Drug

Administered intravenously

Other names: Taxol

Primary outcomes

  1. Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)

    Time frame: Up to approximately 27 months

    PFS, defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever comes first.

  2. Overall Survival (OS)

    Time frame: Up to approximately 47 months

    Overall survival (OS) is defined as time from the date of randomization until death due to any cause.

Secondary outcomes

  1. Objective Response Rate (ORR) as Assessed by BICR

    Time frame: Up to approximately 47 months

    ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1.

  2. Change from Baseline in the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 16

    Time frame: Baseline, Week 16

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. The physical functioning scale range in score from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant).

  3. PFS as Assessed by Investigator

    Time frame: Up to approximately 27 months

    PFS is defined as the time from the date of randomization until the date of objective PD, as assessed by investigator per RECIST v1.1, or death from any cause, whichever comes first

  4. ORR as Assessed by Investigator

    Time frame: Up to approximately 47 months

    ORR is defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1

  5. Duration of Response (DOR) as Assessed by BICR and Investigator

    Time frame: Up to approximately 47 months

    DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD as assessed by BICR and investigator per RECIST v1.1, or death from any cause, whichever comes first.

  6. Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator

    Time frame: Up to approximately 47 months

    CBR is defined as the percentage of participants with best overall response of CR or PR that is confirmed ≥ 4 weeks after initial documentation of response or durable stable disease (SD; duration of SD ≥ 6 months from randomization to disease progression), as assessed by BICR and investigator per RECIST v1.1.

  7. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Time frame: First dose date up to 30 days post last dose (Up to Up to approximately 47 months)

  8. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Time frame: First dose date up to 30 days post last dose (Up to Up to approximately 47 months)

  9. Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 16

    Time frame: Baseline, Week 16

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. Global health status score ranges from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant).

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Asia-Pacific Gynecologic Oncology Trials Group
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • GOG Foundation

Registry information

Official study 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

Acronym: ASCENT-GYN-01

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 3, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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