PER-010-21招募中3 期
A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 with Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer (KEYVIBE-003)
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 109 人开始时间: 2022年1月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 109
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Has a histologically or cytologically confirmed diagnosis of NSCLC (Stage IV: M1a, M1b, M1c).
- •Has measurable disease based on RECIST 1.1, as determined by the local site assessment.
- •Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of the absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], AND absence of ALK and ROS1 gene rearrangements).
- •Has provided tumor tissue that demonstrates PD-L1 expression in =1% of tumor cells (TPS =1%) as assessed by IHC at a central laboratory.
- •Is male or female, = 18 years of age at the time of providing documented informed consent.
- •Has an ECOG PS of 0 or 1 assessed within 7 days prior to randomization.
- •Has a life expectancy of at least 3 months.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding.
- •The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
- •Has adequate organ function.
- •Please refer to the protocol for more information.
排除标准
- •Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks by repeat imaging (note: repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- •Has severe hypersensitivity (=Grade 3) to MK-7684A or pembrolizumab and/or any of its excipients.
- •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.
- •Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- •Has received previous treatment with another agent targeting the TIGIT receptor pathway.
- •Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
研究者
相似试验
进行中（未招募）
1 期
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With lack of normal Red Blood Cells requiring Transfusion and low platelets in the blood Due to Lower Risk Myelodysplastic Syndrome (MDS)EUCTR2012-002471-34-CZCelgene Corporation216
进行中（未招募）
1 期
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With lack of normal Red Blood Cells requiring Transfusion and low platelets in the blood Due to Lower Risk Myelodysplastic Syndrome (MDS)Subjects with Red Blood Cell Transfusion-Dependent Anemia and Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic SyndromesMedDRA version: 20.0Level: LLTClassification code 10068361Term: MDSSystem Organ Class: 100000004864EUCTR2012-002471-34-FICelgene Corporation216
进行中（未招募）
1 期
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With lack of normal Red Blood Cells requiring Transfusion and low platelets in the blood Due to Lower Risk Myelodysplastic Syndrome (MDS)EUCTR2012-002471-34-LTCelgene Corporation386
进行中（未招募）
不适用
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With lack of normal Red Blood Cells requiring Transfusion and low platelets in the blood Due to Lower Risk Myelodysplastic Syndrome (MDS)Subjects with Red Blood Cell Transfusion-Dependent Anemia and Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic SyndromesMedDRA version: 18.1Level: LLTClassification code 10068361Term: MDSSystem Organ Class: 100000004864EUCTR2012-002471-34-DKCelgene Corporation386
进行中（未招募）
1 期
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With lack of normal Red Blood Cells requiring Transfusion and low platelets in the blood Due to Lower Risk Myelodysplastic Syndrome (MDS)EUCTR2012-002471-34-NOCelgene Corporation386