NCT07216703PHASE3RECRUITING

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: Merck Sharp & Dohme LLC + European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Cervical Cancer

Interventions

Pembrolizumab, Sacituzumab Tirumotecan, Bevacizumab, Paclitaxel

Enrollment

1,023 participants

Primary completion

Oct 2031

Study completion

Oct 2031

First posted

Oct 2025

Last updated

May 2026

Primary Endpoints (CT.gov)

Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)

Time frame: Up to approximately 69 months

Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 66 months

Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Time frame: Up to approximately 48 months

Part 2 Maintenance Treatment: Overall Survival (OS)

Time frame: Up to approximately 60 months

Secondary Endpoints

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

Eligibility Criteria

The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix * 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 (surgery and/or radiation) * If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy * If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load * If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load * Has an Eastern Cooperative Oncology Group performance status of 0 or 1 * Has tumor programmed cell death ligand 1 expression of combined positive score ≥1 The main exclusion criteria include but are not limited to the following: * Has HIV i…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov