臨床研究等提出・公開システム

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)

sac-TMT Plus Pembrolizumab as 1L Maintenance in pMMR Endometrial Cancer

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Sept. 01, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR).
2) Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per RECIST 1.1, as assessed by the investigator.
3) 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.

1) Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
2) Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
3) Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment
4) 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
5) Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
6) Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
7) Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
8) 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.

Female

Endometrial cancer

Induction :
- Pembrolizumab 200 mg q3w (6 cycles)
- Carboplatin AUC 5 mg/mL/min q3w (6 cycles)
- Paclitaxel 175 mg/m2 q3w (6 cycles)
Maintenance Treatment Arm A :
- Sac-TMT 4 mg/kg administered on Days 1, 15, and 29 of each 6-week cycle (up to 14 cycles)
- Pembrolizumab 400 mg administered on Day 1 of each 6-week cycle (up to 14 cycles)
Maintenance Treatment Arm B :
- Pembrolizumab 400 mg administered on Day 1 of each 6-week cycle (up to 14 cycles)
Subsequent Treatment Arm A :
- Sac-TMT 4 mg/kg administered on Days 1, 15, and 29 of each 6-week cycle
- Pembrolizumab 400 mg administered on Day 1 of each 6-week cycle (up to 14 cycles)
Subsequent Treatment Arm B :
- Sac-TMT 4 mg/kg administered on Days 1, 15, and 29 of each 6-week cycle

Maintenance Treatment:
- Progression-Free Survival (PFS)
- Overall Survival (OS)

Maintenance Treatment:
- Progression-Free Survival 2 (PFS2) as Assessed by Investigator
- Adverse Events (AEs)
- Study intervention discontinuation due to AEs
- Change from baseline in EORTC QLQ-C30 Global Health Status and QoL, Physical Functioning, Role Functioning
- Change from baseline in EORTC QLQ-EN24

+81-11-811-9111

July. 10, 2025

Yes

https://engagezone.msd.com/

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