EUCTR2017-002546-74-DE进行中（未招募）1 期
Postoperative adjuvant radiochemotherapy (aRCH) with Cisplatin (C) versus aRCH with C and Pembrolizumab (P) in locally advanced head and neck squamous cell carcinoma (HNSCC); multicenter randomized Phase II study within the German interdisciplinary study group of German Cancer Society (IAG KHT); Pembro-Adjuvant-highRisk - ADRISK
niversity Leipzig0 个研究点目标入组 240 人开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- 性别
- All
入选标准
- •1.Macroscopically complete resection of newly diagnosed advanced squamous-cell carcinoma arising in the oral cavity, oropharynx, larynx, or hypopharynx
- •2. Advanced stage III, IVA/B HNSCC according to the TNM classification version 7th edition (Note! The 8th edition will not be used, please adhere to the national cancer institute guidelines)
- •3.Eastern Cooperative Oncology Group performance status of 0 to 1
- •4.Had either intermediate or high-risk characteristics, i.e. any or all of the following:
- •histologic evidence of invasion of two or more regional lymph nodes
- •extracapsular extension of nodal disease,
- •microscopically involved mucosal margins of resection (R1) or margins of resection <= 5mm (R0)
- •5.Had pathological histologic assessment of p16 (only oropharyngeal carcinoma)
- •6.Be >= 18 years
- •7.Written informed consent
- •8.Demonstrate adequate organ function
- •9.Female subject of childbearing potential should have a negative pregnancy test within 3 days prior to receiving the first dose of study medication.
- •10.Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.5.2, for the course of the study through 120 days after the last dose of study medication.
- •11.Reproductive male subjects must agree to use an adequate method of contraception as outlined in Section 5.5.2, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Concurrent participation in any other interventional clinical trial or participation in any other interventional trial within one month before enrolment into this trial.
- •2.Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrolment into this trial.
- •3.Known history of active TB (Bacillus Tuberculosis)
- •4.Hypersensitivity to Pembrolizumab or comparable medicinal products or any of its excipients.
- •5.Prior anti-cancer monoclonal antibody (mAb) therapy within one month before enrolment into this trial or who has not recovered (i.e., = Grade 1 (NCI CTCAE Grade) at baseline) from adverse events due to agents administered more than one month earlier.
- •6.Prior chemotherapy, targeted small molecule therapy, or radiation therapy within one month before enrolment into this trial or who has not recovered (i.e., = grade 1 (NCI CTCAE Grade) at baseline) from adverse events due to a previously administered agent.
- •a.Note: Subjects with = Grade 2 (NCI CTCAE Grade) neuropathy are an exception to this criterion and may qualify for the study.
- •b.Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •7.Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •8.Active autoimmune disease that has required systemic treatment in the past 2 years prior to enrolment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •9.Evidence of interstitial lung disease or history of (non-infectious) pneumonitis that required steroids within the last 6 months before enrolment into this trial, or current pneumonitis.
- •10.Active infection requiring systemic therapy.
- •11.Suspected lack of compliance
- •12.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the baseline visit through 120 days after the last dose of trial treatment.
- •13.HIV, HBV or HCV infection
- •14.Application of a live vaccine within one month of enrolment.
- •Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- •15.Hypersensitivity to cisplatin or any of its excipients
- •16.Any potential relationship to the investigator/his deputy or to medical staff of the study team, to the coordinating investigator or is an employee of the study site
研究者
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