EUCTR2017-003636-36-GB进行中（未招募）1 期
A phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status 2 with recurrent or metastatic squamous cell carcinoma of the head and neck - POPPY
niversity College London0 个研究点目标入组 65 人开始时间: 2018年9月12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
- 65
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. Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies.
- •2. Measurable disease evaluated by RECIST v1.1
- •3. WHO performance status of 2
- •4. Life expectancy of at least 12 weeks
- •5. Aged = 18 years of age
- •6. Adequate bone marrow function:
- •- Absolute neutrophils = 1.5 × 109/L
- •- Platelets = 100 x 109/L
- •- Haemoglobin = 90 g/L
- •7. Adequate renal function:
- •- Creatinine = 1.5 x ULN
- •- Calculated glomerular filtration rate (GFR) = 50 mL/min estimated using validated creatinine clearance calculation (e.g. Cockroft-Gault or Wright formula). 8. Adequate liver function:
- •- Serum bilirubin = 1.5 x ULN
- •- AST and ALT = 2.5 × ULN (= 5 x ULN for patients with liver metastases)
- •9. Willing to use highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment
- •10. Willing to have a new biopsy, if site of disease is accessible and considered safe to biopsy by investigator
- •11. 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
- •12. 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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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. Any investigational agents within 4 weeks prior to registration
- •5. Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
- •6. Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
- •7. Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
- •8. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
- •9. Grade 3 or 4 peripheral neuropathy
- •10. Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician’s judgment, could interfere with patient safety or obtaining informed consent
- •11. 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 for at least four weeks prior to the first dose of trial treatment
- •- Have no evidence of new or enlarging brain metastases
- •- Have no evidence of leptomeningeal disease
- •- Are not using steroids for at least 7 days prior to trial treatment
- •12. Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (hepatitis C virus [HCV] RNA [qualitative] is detected)
- •- NB: Without known history, testing is required to determine eligibility. Hepatitis C antibody testing is allowed for screening purposes in sites where HCV RNA is not part of standard of care
- •13. Immunocompromised patients (e.g. known HIV positive status)*
- •14. Prior organ transplantation including allogenic stem-cell transplantation
- •15. Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
- •16. Active infection requiring systemic therapy
- •17. Has received a live vaccine within 30 days prior to registration (seasonal flu vaccines that do not contain live virus are permitted)
- •18. 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 (NB: the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC)
- •19. Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with the following are eligible:
- •- Autoimmune-related hyperthyroidism or autoimmune-related hypothyroidism who are in remission or on a stable dose of thyroid-replacement hormone
- •- Vitiligo
- •- Psoriasis
- •20. Current use of immunosuppressive medication, except for the following:
- •- intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
- •- Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent
- •- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- •*Testing for HIV for the POPPY trial is not mandatory, however if this test has been done the result should be known prior to registration.
研究者
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