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)

StatusRecruiting

PhasePhase 3

SponsorMerck Sharp & Dohme LLC

Started2026-01-19

View on ClinicalTrials.gov ↗

Amendment history

2026-09-26

Trial sites expanded: 174 → 177 locations

2026-09-09

Study Status, Contacts/Locations v36

Study sites172 entries, revised

Grupo Médico ASSET SC ( Site 2203)

2026-09-01

Study Status, Contacts/Locations v35

Trial sites expanded: 166 → 172 locations

2026-08-27

Study Status, Contacts/Locations v34

Trial sites expanded: 160 → 166 locations

2026-08-20

Study Status, Arms and Interventions, Contacts/Locations v33

Study sites159→160

Show 2 earlier versions

2026-08-05

Study Status, Contacts/Locations v32

Study sites157→159

2026-07-30

Study Status, Contacts/Locations v31

Study sites155→157

2026-07-24

Study Status, Contacts/Locations v30

Trial sites expanded: 150 → 155 locations

2026-07-17

Study Status, Contacts/Locations v29

Trial sites expanded: 145 → 150 locations

2026-07-09

Study Status, Contacts/Locations v28

Trial sites expanded: 138 → 145 locations

2026-06-30

Study Status, Contacts/Locations v27

Trial sites expanded: 135 → 138 locations

2026-06-24

Study Status, Contacts/Locations v26

Trial sites expanded: 130 → 133 locations

2026-06-18

Study Status, Contacts/Locations v25

Study sites130→133

2026-06-11

Study Status, Contacts/Locations v24

Trial sites expanded: 125 → 130 locations

2026-06-04

Study Status, Contacts/Locations v23

Trial sites expanded: 115 → 125 locations

2026-05-29

Study Status, Contacts/Locations v22

Trial sites expanded: 107 → 115 locations

2026-05-21

Study Status, Contacts/Locations v21

Trial sites expanded: 96 → 107 locations

2026-05-13

Study Status, Contacts/Locations v20

Trial sites expanded: 91 → 96 locations

2026-05-06

Study Status, Contacts/Locations v19

Trial sites expanded: 87 → 91 locations

2026-04-30

Study Status, Contacts/Locations v18

Study sites86→87

2026-04-22

Study Status, Contacts/Locations v17

Trial sites expanded: 83 → 86 locations

2026-04-15

Study Status, Contacts/Locations v16

Study sites81→83

2026-04-07

Study Status, Contacts/Locations v15

Trial sites expanded: 64 → 81 locations

Trial sites expanded: 61 → 64 locations

2026-04-01

Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v14

Study sites61→64

Eligibility criteria+153 characters

[...] vix Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics [FIGO]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment [...] dication or previous history of inflammatory bowel disease (~~e.g.~~eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) [...] ystemic treatment in the past 2 years; replacement therapy (~~e.g.~~eg, thyroxine, insulin, or physiologic corticosteroid) is allo [...] ry of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or, has current pneumonitis/~~interstitial~~ILD, ~~lung~~or ~~disease~~ha [...] [...]

Secondary endpoints6 to 7 entries

Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score

Collaborators+82 characters

European Network of Gynaecological Oncological Trial Groups (ENGOT) GOG Foundation

2026-03-19

Study Status, Contacts/Locations v13

Study sites60→61

2026-03-12

Study Status, Contacts/Locations v12

Study sites55→60

2026-03-04

Study Status, Contacts/Locations v11

Study sites47→55

2026-02-27

Study Status, Contacts/Locations v10

Study sites40→47

2026-02-18

Study Status, Contacts/Locations v9

Study sites32→40

2026-02-12

Study Status, Contacts/Locations v8

Study sites23→32

2026-02-04

Study Status, Contacts/Locations v7

Study sites18→23

2026-01-28

Study Status, Contacts/Locations v6

Study sites13→18

2026-01-22

Study Status v5

Start dateestimated 2026-01-20→confirmed 2026-01-19

2026-01-21

Study Status, Contacts/Locations v4

Study sites12→13

2026-01-16

Study Status, Contacts/Locations v3

Study sites7→12

2026-01-09

Study Identification, Study Status, Contacts/Locations v2

Start date2025-12-12→2026-01-20

Study sites1→7

2025-12-01

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start date2025-11-18→2025-12-12

Study sites0→1

2025-10-10

Original filing

Merck (MSD)

401 trials monitored

See 24 trials at risk

Cervical Cancer

853 trials monitored

See 46 trials at risk

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

Trial Details

NCT Number	NCT07216703
Lead Sponsor	Merck Sharp & Dohme LLC Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Conditions	Cervical Cancer
Enrollment	1,023 participants
Start Date	2026-01-19
Primary Completion	2031-10-29 (estimated)
Study Completion	2031-10-29 (estimated)
Updated on ClinicalTrials.gov	2026-09-25