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A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521514-26-00
Acronym
MK-2870-036
Enrollment
317
Registered
2026-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1

Brief summary

Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs), Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review, Part 2 Maintenance Treatment: Overall Survival (OS)

Detailed description

Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator, Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs, Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score

Interventions

DRUG-
DRUGCISPLATIN
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGCARBOPLATIN
DRUGPACLITAXEL

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs), Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review, Part 2 Maintenance Treatment: Overall Survival (OS)

Secondary

MeasureTime frame
Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator, Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs, Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score

Countries

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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026