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Clinical Trials List

Protocol NumberMK-2870-036
NCT Number(ClinicalTrials.gov Identfier)NCT07216703
Active

2025-10-01 - 2034-05-31

Phase III

Recruiting5

ICD-10C53.9

Malignant neoplasm of cervix uteri, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9180.9

Malignant neoplasm of cervix uteri, unspecified

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)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    XXXX

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yun-Hsin Tang Division of Obstetrics & Gynecology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

  • 王功亮 Division of Obstetrics & Gynecology
  • 陳楨瑞 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHI-HAU CHEN CHI-HAU CHEN Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Fang Huang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

  • 石宇翔 Division of Obstetrics & Gynecology
  • 孫珞 Division of Obstetrics & Gynecology
  • 劉芝谷 Division of Obstetrics & Gynecology
  • 王韶靖 Division of Obstetrics & Gynecology
  • 范鈞婷 Division of Obstetrics & Gynecology
  • 黃曉峰 Division of Obstetrics & Gynecology
  • 呂亭芳 Division of Obstetrics & Gynecology
  • 陳彥甫 Division of Obstetrics & Gynecology
  • 吳振豪 Division of Radiology
  • 許世典 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Cervical Cancer

Objectives

Primary Objectives Part 1 (Safety Introduction) • Evaluate the safety and tolerability of sacituzumab tirumotecan (SAC-TMT) plus pembrolizumab with bevacizumab as maintenance therapy. Part 2 Maintenance Therapy • Compare progression-free survival (PFS) of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy versus standard of care (SoC) by blinded independent central review (BICR) according to RECIST version 1.1. • Compare overall survival (OS) of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy versus SoC. Secondary Objectives Part 2 Maintenance Therapy • Evaluate progression-free survival² (PFS²) of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy versus SoC, as assessed by the trial principal investigator. • Evaluate the safety and tolerability of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy. • Evaluate the impact of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy compared to SoC on health-related quality of life (HRQoL) outcomes.

Test Drug

注射劑
注射劑
注射劑

Active Ingredient

Pembrolizumab
Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023
Recombinant humanised monoclonal antibody by DNA technology in Chinese Hamster Ovary cells

Dosage Form

270
270
270

Dosage

25 mg/mL
200 mg/Vial
100 mg/4 ml/Vial (25 mg/ml/vial)

Endpoints

Part 1 (Safety Introduction)

• Evaluate the safety and tolerability of sacituzumab tirumotecan (SAC-TMT) plus pembrolizumab in combination with bevacizumab as maintenance therapy.

Part 2 Maintenance Therapy

• Compare progression-free survival (PFS) of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy versus standard of care (SoC) by a blinded independent central review (BICR) based on the Responsive Criteria for Solid Tumor Response version 1.1 (RECIST 1.1).

• Compare overall survival (OS) of sac-TMT plus pembrolizumab (with or without bevacizumab) as maintenance therapy versus SoC.

Inclution 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 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

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

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

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    1023 participants

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