EUCTR2019-002006-51-FR进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants with Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc0 个研究点目标入组 600 人开始时间: 2019年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Is male or female and is at least 18 years of age on the day of signing informed consent with cTX N+ M0 or cT2-T4 NXM0 ESCC (as defined by AJCC 8th edition), Siewert Type I adenocarcinoma of the EGJ, or EAC, is deemed suitable for dCRT, has disease that is qualitatively evaluable upon radiographic assessment by local site Investigator, and is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist
- •2. Is not be expected to require tumor resection during the course of the study
- •3. Has an ECOG performance status of 0 to 1 within 3 days of the first dose of study intervention
- •4. Is adequately nourished per the Investigator’s judgment. A feeding tube is acceptable to maintain adequate nourishment
- •5. Has provided tumor tissue sample deemed adequate for PD-L1 and MSI biomarker analysis. The PD-L1 result must be determined as positive or negative by the central laboratory and the site notified of its adequacy. Study sites will be masked as to the PDL1 result. A repeat sample will be required if submitted sample is inadequate
- •6. Has adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment
- •7. Male participants are eligible to participate if they agree to the following during the intervention period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater:
- •- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •- Must agree to use contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause):
- •Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
- •8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- •- Is not a Woman of Childbearing Potential (WOCBP)
- •- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
- •- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention
- •The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
排除标准
- •1. Has direct invasion of tumor into adjacent organs such as the aorta or trachea (participants with T4b disease are not eligible for study participation)
- •2. Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during study treatment
- •3. Has had weight loss of >20% in the previous 3 months
- •4. Has had prior chemotherapy or RT for esophageal cancer
- •5. Has had a myocardial infarction within the past 6 months. If the myocardial infarction occurred >6 months ago, participant may be included if no transient ischemia is evident and at the discretion of the Principal Investigator with input from a cardiologist
- •6. Has severe congestive heart failure (ie, NYHA Class 2 or higher)
- •7. Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase, hearing impairment, etc), 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 (eg, any contraindication to the use of cisplatin or 5-FU), in the opinion of the treating Investigator
- •8. 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)
- •9. Has received a live vaccine within 30 days prior to the first dose of study drug. 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 (BCG), 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
- •10. Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents
- •11. Has not recovered from all AEs due to previous non-anticancer therapies to =Grade 1 or baseline. Participants with =Grade 2 neuropathy may be eligible
- •12. Is currently participating in or has participated in a study of an investigational agent for a condition or has used an investigational device within 4 weeks prior to the first dose of study intervention
- •13. 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
- •14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •15. Has severe hypersensitivity (=Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
- •16. 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 insufficienc
研究者
相似试验
进行中（未招募）
1 期
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Alcoholic hepatitisEUCTR2020-004534-38-DEDURECT Corporation300
进行中（未招募）
1 期
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT ChemotherapyFollowed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN)Histologically documented gastric or gastroesophageal junction adenocarcinoma withresectable disease (Stage II or higher per AJCC 8th edition).MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-001555-40-DEAstraZeneca AB900
进行中（未招募）
不适用
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseSecondary hyperparathyroidism in subjects with chronic kidney diseaseMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disordersEUCTR2012-002805-23-ATKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500
进行中（未招募）
1 期
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282
进行中（未招募）
不适用
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseEUCTR2012-002805-23-HUKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500