NL-OMON52613招募中3 期
A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. - MK3475-587
Merck Sharp & Dohme (MSD)0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participants that are currently enrolled in MSD-sponsored
- •pembrolizumab trials and are receiving trial treatment or in a Follow-up
- •Phase at the time KN587 is open. Participants must be from MSD-sponsored
- •pembrolizumab parent trials established by the Sponsor as KN-587 transition
- •2. The participant (or legally acceptable representative if applicable)
- •provides informed consent for the trial and agrees to follow study
- •procedures.
排除标准
- •There are no exclusion criteria to participate in KN587., Participants are
- •excluded from entering Second Course trial treatment once they are enrolled on
- •KN587 if any of the following criteria applies:
- •1. Woman of Childbearing Potential who has a positive urine pregnancy test
- •within 72 hours prior to trial treatment allocation. If the urine test is
- •positive or cannot be confirmed as negative, a serum pregnancy test will be
- •2. Has severe hypersensitivity (>= Grade 3) to pembrolizumab and/or any of its
- •excipients (the list of excipients is provided in the IB).
- •3. Has received a live vaccine within 30 days prior to the first dose of Second
- •Course Phase trial treatment. Examples of live vaccines include, but are not
- •limited to, the following: measles, mumps, rubella, varicella/zoster (chicken
- •pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.
- •Seasonal influenza vaccines for injection are generally killed virus vaccines
- •and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live
- •attenuated vaccines and are not allowed.
- •4. 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 to the Cycle 1 Day 1 of
- •Second Course Phase.
- •5. Has a known additional malignancy that is progressing or requires active
- •treatment. Exceptions include early stage cancers (carcinoma in situ or Stage
- •1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal
- •cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ
- •cervical cancer, or in situ breast cancer that has undergone potentially
- •curative therapy.
- •6. Has known active central nervous system metastases and/or carcinomatous
- •meningitis.
- •7. Has an active autoimmune disease that has required systemic treatment in the
- •past 2 years (ie. 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.
- •8. Has a history of (non-infectious) pneumonitis that required steroids or has
- •current pneumonitis.
- •9. NSCLC participants only: Has interstitial lung disease.
- •10. Has an active infection requiring systemic therapy.
- •11. Has a known history of human immunodeficiency virus infection.
- •12. Has a known history of or is positive for hepatitis B (hepatitis B surface
- •antigen reactive) or hepatitis C (hepatitis C virus RNA [qualitative] is
- •detected). Hepatitis C lab testing is allowed for eligibility purposes in
- •countries where hepatitis C virus RNA is not part of SOC.
- •13. Is pregnant or breastfeeding or expecting to conceive or father children
- •within the projected duration of the trial, starting with the Second Course
- •Phase eligibility Visit through 120 days after the last dose of trial treatment.
- •14. Has severe cardiovascular disease, ie. arrhythmias, requiring chronic
- •treatment, congestive heart failure (New York Heart Association Class III or
- •IV) or symptomatic ischemic heart disease.
- •15. Has hepatic decompensation (Child-Pugh score > 6 [class B and C]).
- •16. Has uncontrolled thyroid dysfunction.
研究者
相似试验
进行中（未招募）
1 期
Extension Study for Participants With Advanced Tumors in Pembrolizumab TrialsAdvanced TumorsMedDRA version: 20.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864EUCTR2017-004417-42-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,955
进行中（未招募）
1 期
Extension Study for Participants With Advanced Tumors in Pembrolizumab TrialsEUCTR2017-004417-42-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,955
进行中（未招募）
1 期
Extension Study for Participants With Advanced Tumors in Pembrolizumab TrialsEUCTR2017-004417-42-IEMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1,955
进行中（未招募）
1 期
Extension Study for Participants With Advanced Tumors in Pembrolizumab TrialsAdvanced TumorsMedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864EUCTR2017-004417-42-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,955
进行中（未招募）
1 期
Extension Study for Participants With Advanced Tumors in Pembrolizumab TrialsEUCTR2017-004417-42-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,955