2025-521514-26-00招募中3 期
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)
研究概览
简要总结
- Part 1 (Safety Run-in) To evaluate the safety and tolerability of maintenance treatment with sac-TMT plus pembrolizumab with bevacizumab
- Part 2 Maintenance Objective: To compare maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab to SoC with respect to PFS per RECIST 1.1 as assessed by BICR.
- Part 2 Maintenance Objective: To compare maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab to SoC with respect to OS.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Has HIV infection with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •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
- •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 sacituzumab tirumotecan
- •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
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)
Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)
Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE
Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE
Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review
Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review
Part 2 Maintenance Treatment: Overall Survival (OS)
Part 2 Maintenance Treatment: Overall Survival (OS)
次要结局
- Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator
- Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs
- Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE
- Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score
- Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score
- Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score
- Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score
研究者
Ved Desai
Scientific
Merck Sharp & Dohme LLC
研究点 (9)
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