2024-516834-36-00招募中3 期
A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 80
- 主要终点
- Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
研究概览
简要总结
- To compare sac-TMT to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
- To compare sac-TMT plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
- To compare sac-TMT to TPC with respect to OS in all participants.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) that cannot be treated with curative intent
- •Has not received systemic treatment for locally recurrent unresectable or metastatic TNBC
- •Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
- •Is a candidate for treatment with pembrolizumab and one of the treatment of physician's choice (TPC) options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
- •Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
- •Human Immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Has breast cancer amenable to treatment with curative intent
- •Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
- •Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
- •History of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or has ongoing surgical complications
- •Has triple-negative breast cancer (TNBC) with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
- •Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic TNBC
- •Has Grade ≥2 peripheral neuropathy
- •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has skin only metastatic disease
- •Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
Overall Survival (OS) (sac-TMT versus TPC)
Overall Survival (OS) (sac-TMT versus TPC)
次要结局
- Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)
- Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)
- Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
- Duration of Response (DOR)
- Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
- Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
- Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
- Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
- Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
- Number of participants who experience one or more adverse events (AEs)
- Number of participants who discontinue study treatment due to an AE
研究者
Karen Lisa Smith
Scientific
Merck Sharp & Dohme LLC
研究点 (80)
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