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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 Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chien-Hsing Lu 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chyong-Huey Lai 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHI-HAU CHEN CHI-HAU CHEN 無
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 Yu-Fang Huang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Endometrial Cancer

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

注射劑
注射劑

Active Ingredient

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
Pembrolizumab (Humanized anti-PD-1 mAb)

Dosage Form

270
270

Dosage

200 mg per vial
25 mg/mL

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:

Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment

Exclusion Criteria

Key exclusion criteria include but are not limited to:

Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment
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
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    1123 participants

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