A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

Conditions

pMMR endometrial carcinoma

Brief summary

Maintenance Treatment: Progression Free Survival (PFS), Maintenance Treatment: Overall Survival (OS)

Detailed description

Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator, Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs), Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE, Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Item Mean Score, Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Maintenance Treatment: Change from baseline in EORTC QLQ Endometrial Cancer Symptom Score (QLQ-EN24)

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCARBOPLATIN

DRUG-

DRUGPARACETAMOL

DRUGCIMETIDINE

DRUGDOCETAXEL

DRUGPACLITAXEL

DRUGMK-2870

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Maintenance Treatment: Progression Free Survival (PFS), Maintenance Treatment: Overall Survival (OS)	—

Secondary

Measure	Time frame
Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator, Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs), Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE, Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Item Mean Score, Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Maintenance Treatment: Change from baseline in EORTC QLQ Endometrial Cancer Symptom Score (QLQ-EN24)	—

Measure

Time frame

Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator, Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs), Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE, Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Item Mean Score, Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Maintenance Treatment: Change from baseline in EORTC QLQ Endometrial Cancer Symptom Score (QLQ-EN24)

—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed