jRCT2080224966已完成1 期
A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination with Cisplatin and Pemetrexed in Treatment-naive Participants with Advanced Malignant Pleural Mesothelioma (KEYNOTE-A17).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- MSD K.K.
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has histologically confirmed diagnosis of advanced/unresectable malignant pleural mesothelioma (MPM)
- •Have at least one measurable disease, which is systemic therapy naive, radiologically assessed by the local site investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST)
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days before the first administration
- •Has a life expectancy of at least 3 months
- •Demonstrate adequate organ function
- •Male participants are eligible to participate if they agree to refrain from donating sperm, plus either agree to remain abstinent or agree to use contraception unless confirmed to be azoospermic
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP), OR is a WOCBP and using a contraceptive method or be abstinent from heterosexual intercourse
排除标准
- •A WOCBP who has a positive pregnancy test within 72 hours prior to treatment allocation
- •Has received prior therapy with an anti-programmed cell-death 1 (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.,CTLA-4, OX-40, CD137)
- •Has previously received systemic anti-cancer therapy (including investigational agents) to MPM. Note: Participants who received (neo) adjuvant previously may be eligible, only if the last dose of chemotherapy was completed at least 6 months before registration. Such participants must have recovered from all adverse events (AEs) due to previous (neo) adjuvant therapies to <=Grade 1 or baseline. Participants with <=Grade 2 neuropathy may be eligible.
- •Received radiation therapy to the lung that is > 30 gray (Gy) within 6 months of the first dose of trial treatment
- •Completed palliative radiotherapy within 7 days of the first dose of trial treatment. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- •Had a major surgery within 3 months prior to the first administration in this study
- •Has received a live vaccine within 30 days prior to the first dose of study drug
- •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 diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
- •Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has had a severe hypersensitivity reaction (>=Grade 3) to treatment a monoclonal antibody/components of the study intervention
- •Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Is being treated for pericardial effusion, or has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- •Has an active infection requiring systemic therapy
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
结局指标
主要结局
-
Safety - Dose limiting toxicities (DLTs) rate - AEs - Discontinuing study treatment due to AEs
次要结局
- Objective response (OR)
- Disease control (DC)
- Duration of response (DOR)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A phase 2 study of pembrolizumab in combination with olaparib in patients with cervical cancer previously treated with platinum-based chemotherapy (GOTIC-025)jRCT203121009628
进行中（未招募）
2 期
A phase 2 study of pembrolizumab in combination with olaparib in patients with cervical cancer previously treated with platinum-based chemotherapyrecurrent or metastatic cervical cancercervical cancer ,Pembrolizumab,OlaparibJPRN-jRCT2031210096Hasegawa Kosei28
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with Maintenance Olaparib or Maintenance Pemetrexed in 1L Metastatic Nonsquamous NSCLCStage IV lung cancer conditionMedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10079440 Term: Non-squamous non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004720-11-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.792
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with Maintenance Olaparib or Maintenance Pemetrexed in 1L Metastatic Nonsquamous NSCLCStage IV lung cancer conditionMedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004720-11-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.792
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in First-Line Metastatic Squamous NSCLCMetastatic Squamous Non-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864EUCTR2018-004721-88-ROMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.735