EUCTR2017-003349-14-DE进行中（未招募）1 期
A randomized phase II study on the optimization of immunotherapy in squamous carcinoma of the head and neck (OPTIM) - OPTIM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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. Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2. Age = 18 years at time of study entry
- •3. Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) or nasal sinus not amenable to local therapies
- •4. Availability of tumor tissue from biopsy for determination of PD-L1 and HPV status according to the following priority ranking: i) recent biopsy (=3 months old) without intervening therapy; ii) any recent biopsy (=3 months old); iii) any archival tumor tissue (> 3 months old) [Biopsy should be excisional, incisional or core biopsy. Fine needle aspiration is not allowed.]
- •5. Progression or recurrence during or after platinum-based palliative chemotherapy for relapsed or metastatic disease
- •progression within 6 months after completion of definitive platinum-containing radiochemotherapy for locally advanced disease
- •6. At least 1 measurable lesion according to RECIST 1.1
- •7. ECOG performance status 0-1
- •8. Completion of local therapy for brain metastases with discontinuation of steroids prior to start of study treatment
- •9. Adequate blood count, liver-enzymes, and renal function:
- •neutrophil count > 1.5 x 10^6/mL
- •platelet count = 100 x 10^9/L (>100,000 per mm^3)
- •hemoglobin = 9 g/dL
- •INR = 1.5 and aPTT = 1.5 x ULN during the last 7 days before therapy
- •AST (SGOT)/ALT (SGPT) < 3 x institutional upper limit of normal (5 x lower limit in case of liver metastases)
- •bilirubin < 1.5 x ULN
- •serum creatinine = 1.5 x institutional ULN or creatinine clearance (CrCl) = 40 mL/min (if using the Cockcroft-Gault formula below):
- •Female CrCl = ((140 - age in years) x weight in kg x 0.85)/(72 x serum creatinine in mg/dL)
- •Male CrCl = ((140 - age in years) x weight in kg x 1.00)/(72 x serum creatinine in mg/dL)
- •10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- •11. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. [WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of nivolumab.] Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) do not require contraception.
- •12. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. [Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of up to 7 months after the last dose of IMP.] Men who are not of childbearing potential (ie, surgically sterile or azoospermic) do not require contraception
- •13. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Medical criteria:
- •1. Nasopharynx carcinoma or carcinoma of salivary glands
- •2. Life expectancy less than 3 months
- •3. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
- •a) Minor surgery = 24 hours prior first dose of nivolumab monotherapy
- •b) Anticancer treatment during the last 30 days prior to start of nivolumab-monotherapy treatment, including systemic therapy, or major surgery [palliative radiotherapy has to be completed at least 2 weeks prior to start of study treatment]
- •c) Known active HBV, HCV or HIV infection
- •d) Active tuberculosis
- •e) Any other active infection requiring systemic therapy
- •f) History of allogeneic tissue/solid organ transplant (including hematopoetic stem cell transplantation)
- •g) Diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy or randomization.
- •h) Has an active autoimmune disease requiring systemic treatment within the past 3 months before enrollment or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study. Psoriasis not requiring treatment is not excluded from the study.
- •i) Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.
- •j) Other active malignancy requiring treatment
- •k) Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrollment
- •l) History or clinical evidence of CNS metastases
- •Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:
- •I. are asymptomatic and
- •II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treament. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases
- •Drug related criteria:
- •4. Medication that is known to interfere with any of the agents applied in the trial.
- •5. Has known hypersensitivity to nivolumab or ipilimumab or docetaxel or any of the constituents of the products.
- •6. Any other efficacious cancer treatment except protocol specified treatment at study start.
- •Safety criteria:
- •7. Patient has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. [Subjects with = Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the study.]
- •8. Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injec
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