臨床研究等提出・公開システム

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 Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOT-ov85/GOG-3102)

sac-TMT in 1L Maintenance Treatment of Non-HRD Positive Advanced EOC

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

Mar. 19, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
- 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.
- If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.
- 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.

- 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, or has current pneumonitis/ILD.
- 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.
- Has active or ongoing stomatitis of any grade.

Female

Ovarian cancer

Arm 1:
- sac-TMT 4 mg/kg IV, Days 1, 15, and 29 (every 2 weeks, q2w) of every 6-week cycle, until disease progression or prohibitive toxicity, or other protocol-defined reason for discontinuation.
WITH OR WITHOUT
- Bevacizumab 15 mg/kg IV, Days 1 and 22 (every 3 weeks, q3w) of every 6-week cycle for up to 22 courses (including 1L platinum-based chemotherapy [up to 6 courses], screening period, and maintenance therapy) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention.
Arm 2:
- Bevacizumab 15 mg/kg IV, Days 1 and 22 (q3w) of every 6-week cycle for up to 22 courses (including 1L platinum-based chemotherapy [up to 6 courses], screening period, and maintenance therapy) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention.
Note: Participants who received bevacizumab in combination with 1L platinum-based chemotherapy and have a response of SD at the time of screening must continue with bevacizumab as in 1L maintenance treatment.
- Observation (for participants not receiving bevacizumab).

To compare sac-TMT maintenance treatment with or without bevacizumab to standard-of-care (SoC), with respect to progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR)

- To compare sac-TMT maintenance treatment with or without bevacizumab to SoC with respect to overall survival (OS)
- To evaluate PFS2 as determined by the investigator
- To evaluate the safety and tolerability of sac-TMT maintenance treatment with or without bevacizumab
- To evaluate sac-TMT maintenance treatment with or without bevacizumab versus SoC with respect to the mean change from baseline of GHS/QoL score using the EORTC QLQ-C30 and abdominal/GI symptoms using the EORTC QLQ-OV28 abdominal/GI symptom scale

+81-25-266-5111

Dec. 08, 2025

Yes

https://engagezone.msd.com/

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