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Clinical Trials List

Protocol NumberMK-2870-021
NCT Number(ClinicalTrials.gov Identfier)NCT07318558
Active

2026-01-16 - 2033-12-31

Phase III

Recruiting5

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOT-ov85/GOG-3102)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    MERCK SHARP & DOHME (I.A.) LLC. TAIWAN BRANCH (U.S.A.)

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/11

Investigators and Locations

Principal Investigator Yu-Fang Huang Division of Obstetrics & Gynecology
National Taiwan University Hospital

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

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

Co-Principal Investigator

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

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIU-JUNG TUNG
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Ovarian Neoplasms Ovarian Cancer

Objectives

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Test Drug

MK-2870
艾法施®/MVASI®

Active Ingredient

Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023
BEVACIZUMAB
BEVACIZUMAB

Dosage Form

Injection
Injection

Dosage

200 mg
100 mg
400mg

Endpoints

Progression-Free Survival (PFS) PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

Inclution Criteria

Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present.
Has completed primary debulking surgery or interval debulking surgery.
Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
Has provided tumor tissue that is not previously irradiated.
Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.

Exclusion Criteria

Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a history of severe eye disease.
Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.
Had a live or live-attenuated vaccine within 30 days of randomization.
Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
Has active infection requiring systemic therapy.
Has concurrent and active HBV and HCV infections.
Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
Has not recovered from major surgery or has ongoing surgical complications.
Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
Active or ongoing stomatitis of any grade.

The Estimated Number of Participants

  • Taiwan

    37 participants

  • Global

    900 participants

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