NCT07216703

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

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: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,023 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

Detailed description

This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Intravenous (IV) Infusion
BIOLOGICAL	Sacituzumab Tirumotecan	IV Infusion
BIOLOGICAL	Bevacizumab	IV Infusion
DRUG	Paclitaxel	IV Infusion
DRUG	Cisplatin	IV Infusion
DRUG	Carboplatin	IV Infusion
DRUG	Rescue Medications	Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).

Timeline

• Start date: 2026-01-19
• Primary completion: 2031-10-29
• Completion: 2031-10-29
• First posted: 2025-10-14
• Last updated: 2026-04-17

Locations

83 sites across 17 countries: United States, Argentina, Belgium, Brazil, Canada, Colombia, Czechia, Greece, Hungary, Israel, Italy, Japan, Poland, South Korea, Spain, Sweden, Taiwan

Regulatory

• FDA-regulated drug study