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)
Sponsor: European Network of Gynaecological Oncological Trial Groups (ENGOT)
Listed as NCT07216703, this observational or N/A phase trial focuses on Cervical Cancer and remains actively recruiting participants. Sponsored by European Network of Gynaecological Oncological Trial Groups (ENGOT), it has been updated 7 times since 2026, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
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Apr 28, 2026 — May 4, 2026 [daily]
Recruiting
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Apr 18, 2026 — Apr 28, 2026 [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
▶ Show 2 earlier versions
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Nov 2025 — Jan 2026 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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
Contact Information
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
- GOG Foundation
- Merck Sharp & Dohme LLC
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Akashi, Japan , Athens, Greece , Athens, Greece , Barcelona, Spain , Barranquilla, Colombia , Barretos, Brazil , Belgrano, Argentina , Bogotá, Colombia , Brussels, Belgium , Budapest, Hungary and 77 more locations