EUCTR2017-003592-64-GB进行中（未招募）1 期
A randomised phase II study evaluating the safety and anti-tumour activity of the combination of avelumab and cetuximab relative to avelumab monotherapy in recurrent/metastatic head and neck squamous cell cancer - EACH
niversity College London0 个研究点目标入组 130 人开始时间: 2017年12月5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
- 130
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. Histologically/cytologically confirmed recurrent/metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies. (NB: for the safety run-in, this criterion is replaced by Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma that is considered incurable by local therapies.)
- •2. Prior treatment with a platinum agent (either for recurrent/metastatic disease; or as part of radical intent multi-modality treatment if disease has recurred within 6 months). (NB: This cirterion is not applicable for the safety run-in).
- •3. No previous treatment with cetuximab for metastatic/recurrent disease
- •4. Age =18 years
- •5. WHO Performance Status 0 or 1
- •6. Measurable disease according to RECIST v1.1
- •7. Adequate bone marrow function
- •8. Adequate liver function
- •9. Adequate renal function
- •10. Adequate venous access for administration of treatment and collection blood samples for exploratory biological samples
- •11. Willing to have a new biopsy (NB: This criterion is not applicable for the safety run-in).
- •12. Life expectancy of >3 months
- •13. Women of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods from date of informed consent, which must be continued for 120 days after completion of trial treatment.
- •14. Able to give informed consent, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
- •15. Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Patients with undifferentiated nasopharyngeal or sino-nasal cancers.
- •2. Disease suitable for treatment with curative intent.
- •3. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.
- •4. Treatment with any investigational agent within 4 weeks prior to the first dose of trial treatment.
- •5. Anti-cancer monoclonal antibody therapy within 4 weeks prior to randomisation
- •6. Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to randomisation.
- •7. Persisting grade =2 toxicity related to prior therapy
- •8. Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial.
- •9. Women who are pregnant or breast feeding.
- •10. Grade 3 or 4 peripheral neuropathy.
- •11. Any serious and/or unstable pre-existing medical, psychiatric or other condition, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •12. Patients who are not able to give informed consent for any reason.
- •13. Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •14. Hepatitis infection at screening
- •15. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- •16. Prior organ transplantation including allogenic stem-cell transplantation
- •17. Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
- •18. Active infection requiring systemic therapy
- •19. Has received a live vaccine within 28 days prior to first dose of trial treatment
- •20. 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 (n.b. the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC)
- •21. Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
- •22. Current use of immunosuppressive medication
- •23. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organising pneumonia (i.e. bronchiolitis obliterans, cryptogenic organising pneumonia), or evidence of active pneumonitis on screening chest CT scan. (History of radiation pneumonitis in the radiation field is permitted).
- •24. Significant cardiovascular disease
- •25. Known prior severe hypersensitivity to either investigational product or any component in their formulations, including known severe hypersensitivity reactions to monoclonal antibodies
- •26. Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis.
- •27. Patients with a history of keratitis, ulcerative keratitis or severe dry eye.
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