Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy

JRCT ID: jRCT2051240165

Registered date:17/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Endometrial Cancer
• Date of first enrollment: 29/11/2024
• Target sample size: 520
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

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
Drug: Doxorubicin
Administered intravenously
Other Names: Adriamycin
- Paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of a 28-day cycle
Drug: Paclitaxel
Administered intravenously
Other Names: Taxol

Outcome(s)

Primary Outcome

- 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 RECIST v1.1, or death from any cause, whichever comes first.

- Overall Survival (OS) [Time Frame: Up to approximately 47 months]
OS is defined as time from the date of randomization until death due to any cause.

Secondary Outcome

- Objective Response Rate (ORR) as Assessed by BICR and Investigator [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.

- 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 13 [Time Frame: Baseline, Week 13]
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).

- PFS as Assessed by Investigator [Time Frame: Up to approximately 27 months]

- 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.

- 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.

- 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)]

- 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)]

- Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain of the EORTC QLQ-C30 at Week 13 [Time Frame: Baseline, Week 13]
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).

Key inclusion & exclusion criteria

• Age minimum: > 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

- Eastern Cooperative Oncology Group performance status score of 0 or 1.

- Adequate organ function.

Exclude 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.

Related Information

• Primary Sponsor: Funayama Keiji
• Secondary ID(s): NCT06486441,2024-511957-23