NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ovarian cancer
Date of first enrollment	11/03/2026
Target sample size	45
Countries of recruitment	United States of America,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Peru,Japan,Austria,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Turkey,Japan,UK,Japan,Australia,Japan,Refer to 7-5,Japan
Study type	Interventional
Intervention(s)	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).

Outcome(s)

Primary Outcome

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)

Secondary Outcome

- 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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	- 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.
Exclude criteria	- 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.