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Clinical Trials List

Protocol NumberMK-2870-033
NCT Number(ClinicalTrials.gov Identfier)NCT06952504
Active

2025-04-01 - 2032-12-31

Phase III

Recruiting5

ICD-10C54.1

Malignant neoplasm of endometrium

ICD-10C54.2

Malignant neoplasm of myometrium

ICD-10C54.3

Malignant neoplasm of fundus uteri

ICD-10C54.9

Malignant neoplasm of corpus uteri, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9182.0

Malignant neoplasm of corpus uteri, except isthmus

A phase 3, randomized, open-label, multicenter trial was conducted in mismatched patients with intact endometrial cancer to compare the efficacy and safety of sacituzumab tirumotecan (Sac-TMT, MK-2870) plus pembrolizumab versus pembrolizumab alone as first-line maintenance therapy (TroFuse-033/GOG-3119/ENGOT-en29).

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck & Co., Ltd. Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/06

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 無
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 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chyong-Huey Lai
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Progression-free survival (PFS): Time from randomization to the first recorded disease progression or death from any cause, whichever occurs first. Overall survival (OS): Time from randomization to death from any cause.

Objectives

Primary Objectives: (1) The primary objective of maintenance therapy: To compare progression-free survival (PFS) of patients with pMMR primary advanced or recurrent endometrial cancer, assessed by a blinded independent central review (BICR) according to the Responsive Criteria in Solid Tumor Response (RECIST) version 1.1, with sacituzumab tirumotecan plus pembrolizumab as maintenance therapy versus pembrolizumab alone. (2) To compare overall survival (OS) of patients with pMMR primary advanced or recurrent endometrial cancer, with sacituzumab tirumotecan plus pembrolizumab as maintenance therapy versus pembrolizumab alone.

Test Drug

Pembrolizumab (MK-3475)
Sacituzumab Tirumotecan (MK-2870)

Active Ingredient

Pembrolizumab (Humanized anti-PD-1 mAb)
an ADC consisting of 1) a TROP2-targeting mAb, sacituzumab; 2) a cytotoxic payload in the class of topoisomerase I inhibitors, KL610023; and 3) a novel, irreversible but hydrolyzable linker which joins the mAb and the cytotoxic drug payload
an ADC consisting of 1) a TROP2-targeting mAb sacituzumab; 2) a cytotoxic payload in the class of topoisomerase I inhibitors KL610023; and 3) a novel irreversible but hydrolyzable linker which joins the mAb and the cytotoxic drug payload

Dosage Form

Injectables
Injectables

Dosage

25 mg/mL
200 mg per vial
160 mg per vial

Endpoints

Progression-free survival (PFS): Time from randomization to the first recorded disease progression or death from any cause, whichever occurs first.
Overall survival (OS): Time from randomization to death from any cause.

Inclution Criteria

Key inclusion criteria include, but are not limited to:

• Histologically confirmed primary advanced or recurrent endometrial cancer with confirmed mismatched repair intact (pMMR).

• Presence of radiographically evaluable disease, assessed by the trial administrator as measurable stage III disease, or measurable or non-measurable stage IV disease, or recurrent disease according to RECIST 1.1.

• No prior systemic therapy for endometrial cancer, except as specified in the trial protocol: prior first-line systemic platinum-based adjuvant chemotherapy and/or lead chemotherapy for curative purposes; prior radiation therapy (with or without radiosensitizing chemotherapy) >2 weeks prior to induction therapy; or prior hormone therapy for endometrial cancer, but which must have been discontinued ≥1 week prior to induction therapy.

Exclusion Criteria

The main exclusion criteria include, but are not limited to:

• Carcinosarcoma, neuroendocrine tumor, or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcoma

• Any endometrial cancer histologically characterized as mismatched repair deficiency (dMMR)

• Suitable for radical surgery or radical radiotherapy at the time of enrollment

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

• Active inflammatory bowel disease requiring immunosuppressive drugs, or a history of... • History of inflammatory bowel disease

• Uncontrolled major cardiovascular or cerebrovascular disease

• Human immunodeficiency virus infection with a history of Kaposi's sarcoma and/or multicentric Kassmann's disease

• Previous treatment with any of the following: anti-programmed cell death protein 1, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor; trophoblast surface antigen 2-targeted antibody-drug complexes; or antibody-drug complexes containing a type I topoisomerase inhibitor.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    1123 participants

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