臨床研究等提出・公開システム

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 First-line 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)

sac-TMT + pembrolizumab +- bevacizumab as 1L maintenance for cervical cancer

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Dec. 15, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix.
- Has persistent, recurrent, or newly diagnosed metastatic 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.

- Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Has received prior systemic anticancer therapy other than what is specified in this protocol.
- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT.
- Has a diagnosis of immunodeficiency.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a history of stem cell/solid organ transplant.
- Has not adequately recovered from major surgery or has ongoing surgical complications.

Female

Adenocarcinoma of the cervix

Part 1 (Safety Run-in)
Maintenance single arm:
- sac-TMT 4 mg/kg every 2 weeks (q2w) + pembrolizumab 400 mg every 6 weeks (q6w) + bevacizumab 15 mg/kg every 3 weeks (q3w)

Part 2
Induction:
- Pembrolizumab 200 mg q3w + paclitaxel 175 mg/m2 q3w + cisplatin 50 mg/m2 q3w (or carboplatin AUC5 mg/mL/min q3w) +- bevacizumab 15 mg/kg q3w at investigator's discretion

Maintenance:
- Arm A: sac-TMT 4 mg/kg q2w + pembrolizumab 400 mg q6w +- bevacizumab 15 mg/kg q3w at investigator's discretion
- Arm B: pembrolizumab 400 mg q6w +- bevacizumab 15 mg/kg q3w at investigator's discretion

Part 1 (Safety Run-in)
- One or More AdverseEvents (AEs)
- Study intervention discontinuation due to AEs

Part 2 Maintenance
- Progression-free Survival (PFS): The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first
- Overall survival (OS): The time from randomization to death due to any cause

Part 2 Maintenance
- Progression-free Survival 2 (PFS2): The time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first
- AEs
- Study intervention discontinuations due to AEs
- Change from baseline in:
-European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/quality of life
-EORTC QLQ-C30 physical functioning score
-EORTC QLQ-C30 role functioning score

+81-25-266-5111

Nov. 14, 2025

Yes

https://engagezone.msd.com/

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