2023-508253-98-00招募中3 期
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 167
- 试验地点
- 31
- 主要终点
- Progression-Free Survival (PFS) per RECIST 1.1 assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
- To compare progression-free survival (PFS) between treatment groups.
- To compare overall survival (OS) between treatment groups.
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
- 是
入选标准
- •Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
- •HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
- •Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the site investigator
- •Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
- •Has a life expectancy of greater than 6 months
- •Has adequate organ function
排除标准
- •Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
- •Has an active infection requiring systemic therapy
- •Has poorly controlled diarrhea
- •Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •Has peripheral neuropathy > Grade 1
- •Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- •A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
- •Has active or clinically significant cardiac disease
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- •Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
- •Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
- •Has had an allogeneic tissue/solid organ transplant
- •Has received prior therapy with an anti-programmed cell death1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])
- •Has had radiotherapy within 14 days of randomization
- •Has a 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
- •Has an active autoimmune disease that has required systemic treatment in past 2 years
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- •Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
结局指标
主要结局
Progression-Free Survival (PFS) per RECIST 1.1 assessed by Blinded Independent Central Review (BICR)
Progression-Free Survival (PFS) per RECIST 1.1 assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR
- Duration of Response (DOR) per RECIST 1.1 assessed by BICR
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Kanu Priya Sharan
Scientific
Merck Sharp & Dohme LLC
研究点 (31)
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