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Clinical Trials List

Protocol NumberMK-2870-022
NCT Number(ClinicalTrials.gov Identfier)NCT06824467
Active

2025-02-01 - 2033-12-31

Phase III

Recruiting5

ICD-10C56.1

Malignant neoplasm of right ovary

ICD-10C56.2

Malignant neoplasm of left ovary

ICD-10C56.9

Malignant neoplasm of unspecified ovary

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9183.0

Malignant neoplasm of ovary

A phase 3, randomized, open-label, multicenter trial was conducted in patients with platinum-sensitive recurrent ovarian cancer to evaluate the efficacy and safety of sacituzumab tirumotecan (MK-2870) maintenance therapy with or without bevacizumab compared to standard care after second-line platinum-based doublet chemotherapy (TroFuse-022/ENGOT-ov84/GOG-3103).

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck & Co., Ltd. Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/26

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 Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General 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 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

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

Part 1: (1) Adverse events (AEs) (2) Discontinuation of trial treatment due to AEs Part 2: (1) PFS: Time from randomization to the first recorded disease progression or death from any cause, whichever occurs first.

Objectives

Primary Objectives Part 1: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance therapy combined with bevacizumab Part 2: To compare the progression-free survival (PFS) of sacituzumab tirumotecan maintenance therapy with or without bevacizumab versus SoC (with or without bevacizumab) as assessed by a blinded independent central review (BICR) according to the Responsive Criteria for Solid Tumor Response (RECIST) 1.1. Secondary Objectives Part 2: To compare the overall survival (OS) of sacituzumab tirumotecan maintenance therapy with or without bevacizumab versus SoC Part 2: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance therapy with or without bevacizumab Part 2: To evaluate sacituzumab Tirumotecan maintenance therapy with or without bevacizumab compared to SoC, using the mean change since baseline in the overall health status/quality of life (QoL) score of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and abdominal/GI symptoms using the EORTC Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28) Abdominal/Gastrointestinal (GI) Symptom Scale.

Test Drug

Dexamethasone
MK-2870
MVASI

Active Ingredient

DEXAMETHASONE
MK-2870
BEVACIZUMAB

Dosage Form

Oral solution
Injection
Injection

Dosage

0.5 mg/5 mL 500mL/Bottle
200mg
100 mg, 400 mg

Endpoints

Part 1:

(1) Adverse events (AEs)

(2) Discontinuation of trial treatment due to AEs

Part 2:

(1) PFS: Time from randomization to the first recorded disease progression or death from any cause, whichever occurs first.

Inclution Criteria

• Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

• Received four or more cycles of platinum-based doublet chemotherapy as first-line treatment for ovarian cancer (OC), and subsequently received six cycles of carboplatin-based doublet chemotherapy as second-line treatment.

• Patients with epithelial OC sensitive to platinum-based drugs

• Previously unirradiated tumor lesion tissue has been provided

• Subjects infected with human immunodeficiency virus (HIV) must have achieved good HIV control through antiretroviral therapy

• Subjects who are hepatitis B surface antigen positive, have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and whose HBV viral load is undetectable before allocation (Part 1) or randomization (Part 2) are eligible

• Subjects with a history of hepatitis C virus (HCV) infection, but whose HCV viral load is undetectable at screening, are eligible

• Eastern Coast Cancer Clinical Research Cooperative (ECOG) performance status of 0 to 1, assessed within 7 days prior to allocation (Part 1) or randomization (Part 2).

Exclusion Criteria

• History of non-epithelial carcinoma (germ cell tumors and sex cord-stromal tumors), marginal tumors (low-grade malignancies), mucinous tumors, seromucous tumors predominantly mucinous, malignant Brenner's tumors, and undifferentiated carcinomas.

• History of platinum-resistant or platinum-refractory OC.

• Documented history of severe dry eye, severe meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.

• History of active inflammatory bowel disease requiring immunosuppressive medication, or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).

• History of uncontrolled major cardiovascular or cerebrovascular disease.

• History of (non-infectious) pneumonia/interstitial lung disease requiring steroid use, or current history of pneumonia/interstitial lung disease.

• Subjects with HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman disease

• Subjects who have received more than two lines of prior systemic OC therapy

• Subjects who have received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to allocation (Part 1) or randomization (Part 2)

• Subjects who have received prior radiation therapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or have radiation-related toxicity requiring corticosteroids

• Subjects with known other malignancies that are worsening or require aggressive treatment within the past 3 years

• Subjects with known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Subjects with active infections requiring systemic therapy

The Estimated Number of Participants

  • Taiwan

    23 participants

  • Global

    770 participants

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