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临床试验/EUCTR2017-002122-20-DE
EUCTR2017-002122-20-DE进行中（未招募）1 期

Randomized phase II study of immune stimulation with Pembrolizumab and radiotherapy in second line therapy of metastatic head and neck squamous cell carcinoma (IMPORTANCE) - IMPORTANCE

Dean of the Medical Faculty of the Friedrich-Alexander University Erlangen-Nürnberg Prof. Dr. med. Markus F. Neurath0 个研究点目标入组 130 人开始时间: 2018年1月22日最近更新:
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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
130
研究概览入排标准研究者记录与标识符相似试验

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

  • •In order to be eligible for participation in this trial, the subject must:
  • •1. Be willing and able to provide written informed consent/ assent for the trial.
  • •2. Be = 18 years of age on day of signing informed consent.
  • •3. Metastatic HNSCC or metastatic squamous cell CUP (carcinoma of unknown primary) of the neck (at least two distinct lesions: Lesion planned for radiotherapy with =2ml tumor volume, or =3 lesions: 1 lesion planned for radiotherapy with =2ml tumor volume or 2 lesions planned for radiotherapy with a cumulative tumor volume =2ml)
  • •Locally recurrent HNSCC not suitable for curative local treatment within or outside the previously irradiated tissue (at least two distinct lesions: Lesion planned for radiotherapy with =2 ml tumor volume, or =3 lesions: 1 lesion planned for radiotherapy with =2 ml tumor volume or 2 lesions planned for radiotherapy with a cumulative tumor volume =2ml).
  • •At least in one of these lesions must be a need for radiotherapy in near future (as defined in inclusion criterion 4).
  • •4. Need for radiotherapy in near future as defined in the following. At least one of the following criteria must be fulfilled:
  • •Primary tumor causing mild pain or swallowing problems
  • •Lymph node or soft tissue metastasis with distance less than 1 cm to the skin (radiotherapy to prevent weeping tumor infiltration of the skin or fistula)
  • •Bone metastases causing mild pain (without risk of fracture)
  • •Lung metastases, lymph node metastases, liver metastases or adrenal gland metastases with a diameter above 1 cm in an oligometastatic situation (defined as a maximum of 5 tumor lesions)
  • •Lung metastases or mediastinal lymph node metastases causing hemoptysis or permanent severe dry cough
  • •Lung metastases or mediastinal lymph node metastases close to trachea or main bronchus (radiotherapy to prevent tumor infiltration and bleeding)
  • •Liver metastases causing intrahepatic bile duct obstruction.
  • •5. Progression after first line platinum-based or any second/ third line chemotherapy
  • •Progression within 6 months after platinum-based radiochemotherapy of locally advanced disease
  • •First line treatment if PD-L1 CPS (combined positive score) =1.
  • •6. Histological confirmation of HNSCC or squamous cell CUP (carcinoma of unknown primary) of the neck.
  • •7. Have at least one measurable lesion according to iRECIST that receives less than 10% of the prescribed dose of the irradiated lesion(s) (not considering doses from previous radiotherapy).
  • •8. Have a performance status of 0-1 on the ECOG Performance Scale.
  • •9. Demonstrate adequate organ function as defined in table 2, all screening labs should be performed within 10 days of treatment initiation.
  • •10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. A highly sensitive pregnancy test must be used. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • •11. Female subjects of childbearing potential (Section 5.7.2) must be willing to use a highly effective contraceptive measure as defined in the Clinical Trial Facilitation Group (CTFG) guideline (Recommendations related to contraception and pregnancy testing in clinical trials.”) For details see Section 5.7.2 of the study protocol. Highly effective contraception is required for the course of the study through 120 days after the last dose of study medication.
  • •12. Generative male

排除标准

  • •The subject must be excluded from participating in the trial if the subject:
  • •1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • •2. Has need for palliative radiotherapy for symptomatic metastases. This includes the following situations:
  • •New or progressive central nervous system metastases
  • •Metastases causing significant pain
  • •Instable bone metastases
  • •Lung metastases or mediastinal lymph node metastases with active bleeding
  • •3. Other metastases that require prompt radiotherapy in the opinion of the investigatorHas only a tumor lesion perspectively requiring re-irradiation after prior radiotherapy less than three months ago.
  • •4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • •5. Has a known history of active TB (Bacillus Tuberculosis).
  • •6. Hypersensitivity to pembrolizumab or any of its excipients.
  • •7. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., = grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.
  • •8. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., = grade 1 or at baseline) from AEs due to a previously administered agent.
  • •Note: Subjects with = grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • •Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • •9. Has known history or concurrent other malignancy. Exceptions include patients, who have been disease free for at least five years. Further exceptions are completely resected basal cell carcinoma or squamous cell carcinoma of the skin or successfully treated in situ carcinoma.
  • •10. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • •11. Has active autoimmune disease that has required systemic treatment in the past 2 years (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.
  • •12. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • •13. Has an active infection requiring systemic therapy.
  • •14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the

研究者

发起方
Dean of the Medical Faculty of the Friedrich-Alexander University Erlangen-Nürnberg Prof. Dr. med. Markus F. Neurath

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