NIPH Clinical Trials Search

sac-TMT + pembrolizumab +- bevacizumab as 1L maintenance for cervical cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Adenocarcinoma of the cervix
Date of first enrollment	23/01/2026
Target sample size	68
Countries of recruitment	United States of America,Japan,Argentina,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Czech Republic,Japan,Chile,Japan,Colombia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Philippines,Japan,Poland,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	Part 1 (Safety Run-in) Maintenance single arm: - sac-TMT 4 mg/kg every 2 weeks (q2w) + pembrolizumab 400 mg every 6 weeks (q6w) + bevacizumab 15 mg/kg every 3 weeks (q3w) Part 2 Induction: - Pembrolizumab 200 mg q3w + paclitaxel 175 mg/m2 q3w + cisplatin 50 mg/m2 q3w (or carboplatin AUC5 mg/mL/min q3w) +- bevacizumab 15 mg/kg q3w at investigator's discretion Maintenance: - Arm A: sac-TMT 4 mg/kg q2w + pembrolizumab 400 mg q6w +- bevacizumab 15 mg/kg q3w at investigator's discretion - Arm B: pembrolizumab 400 mg q6w +- bevacizumab 15 mg/kg q3w at investigator's discretion

Outcome(s)

Primary Outcome

Part 1 (Safety Run-in) - One or More AdverseEvents (AEs) - Study intervention discontinuation due to AEs Part 2 Maintenance - Progression-free Survival (PFS): The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first - Overall survival (OS): The time from randomization to death due to any cause

Secondary Outcome

Part 2 Maintenance - Progression-free Survival 2 (PFS2): The time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first - AEs - Study intervention discontinuations due to AEs - Change from baseline in: -European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/quality of life -EORTC QLQ-C30 physical functioning score -EORTC QLQ-C30 role functioning score

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	- Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix. - Has persistent, recurrent, or newly diagnosed metastatic cervical cancer that is not amenable to curative treatment (surgery and/or radiation). - If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy. - If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load. - If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load. - Has an Eastern Cooperative Oncology Group performance status of 0 or 1. - Has tumor programmed cell death ligand 1 expression of combined positive score >=1.
Exclude criteria	- Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - 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 (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. - Has received prior systemic anticancer therapy other than what is specified in this protocol. - Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT. - Has a diagnosis of immunodeficiency. - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. - Has known active central nervous system metastases and/or carcinomatous meningitis. - Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed. - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. - Has a history of stem cell/solid organ transplant. - Has not adequately recovered from major surgery or has ongoing surgical complications.