EUCTR2020-004918-35-ES进行中（未招募）1 期
A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination with Retifanlimab or Tebotelimab in the First-Line Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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.Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient’s disease.
- •2.Age = 18 years old.
- •3.Histologically proven, recurrent or metastatic SCCHN not curable by local therapy.
- •4.No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease).
- •5.Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx (any histology).
- •6.All patients enrolled in this study must have an identified formalin-fixed, paraffin embedded (FFPE) tumor specimen for immunohistochemical evaluation of pharmacodynamic markers of interest. If no archival specimen is available, tissue from a contemporaneous core or excisional biopsy is acceptable.
- •Patients must also be willing to provide consent for a baseline and on treatment tumor biopsy, if tumor lesions are accessible for biopsy with acceptable risk in the judgment of the Investigator and after discussion with the Sponsor. This requirement will expire after an adequate number of samples have been collected, as determined by the Sponsor.
- •7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, verified within 3 days before Day 1.
- •8.Life expectancy = 6 months.
- •9.Has adequate end organ function as determined by the site Investigator.
- •10.Has at least one radiographically measurable lesion (target lesion), as defined in RECIST v1.1 and documented by computed tomography (CT) or magnetic resonance imaging (MRI), suitable for response monitoring.
- •11.Has PD-L1 expression level that is either:
- •a.Positive (CPS = 1) for the Retifanlimab Cohort, or
- •b.Negative (CPS < 1) for the Tebotelimab Cohort
- •12.Has results from testing of HPV p16 status for oropharyngeal cancer.
- •13.Acceptable laboratory parameters as follows:
- •a.Platelet count = 100 × 103/µL without transfusion within 28 days prior to the initiation of study drug.
- •b.Absolute neutrophil count = 1.5 × 103/µL in the absence of any growth factor support within 28 days prior to the initiation of study drug.
- •c.ALT/AST = 2.5 × ULN; for patients with hepatic metastases, ALT and AST = 5 × ULN.
- •d.Total bilirubin < 1.5 × ULN, except patients with Gilbert’s syndrome, who may enroll if the conjugated bilirubin is within normal limits.
- •e.Creatinine < 2 mg/dL, or a calculated or measured creatinine clearance > 50 mL/min.
- •f.Negative serum pregnancy test, if applicable.
- •14.Women patients of child bearing potential (WOCBP), defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and between menarche and 1-year post menopause, must have a negative serum pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female patients must agree to abstain from egg donation during the course of the study.
- •15.WOCBP and male patients with partners of WOCBP must agree to use highly effective methods of contraception from the time of consent through 120 days after discontinuation of study drug administration. Male patients must agree to abstain from sperm donation during the course of the study.
- •16.WOCBP is not pregnant or breastfeeding or male patient is not expecting to father children within the projected duration
排除标准
- •1.Disease suitable for local therapy administered with curative intent.
- •2.Has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN.
- •3.Radiation therapy (or other non-systemic therapy) within 2 weeks prior to the first dose of study drug.
- •4.Toxicity of prior therapy that has not recovered to = Grade 1 or baseline, with the exception of any grade of alopecia and anemia not requiring transfusion support.
- •5.Diagnosis of immunodeficiency or receiving systemic steroid therapy corticosteroids or any other form of immunosuppressive therapy within 14 days prior to the first dose of study medication.
- •6.Currently participating in a study of an investigational agent and receiving study therapy, participated in a study of an investigational agent and received study therapy, or used an investigational drug or device within 4 weeks of the first dose of study drug administration.
- •7.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, including:
- •a.Participants who are known to be HIV-positive, unless all the following criteria are met:
- •- CD4+ count = 300/µL,
- •-Undetectable viral load, and
- •-Receiving highly active antiretroviral therapy.
- •b.Known history of or current acute or chronic hepatitis B virus (HBV) infection.
- •c.Patients with a history of hepatitis C virus (HCV) infection, unless the infection has been treated and cured.
- •d.Has had an allogeneic stem cell or tissue/solid organ transplant.
- •e.Patients with central nervous system metastases and/or carcinomatous meningitis.
- •f.Patients with a history of psoriatic arthritis.
- •g.Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years and patients with a history of autoimmune disease who are now clinically stable with replacement therapy and by laboratory testing.
- •h.Evidence of active viral, bacterial, or systemic fungal infection requiring systemic treatment within 7 days prior to the initiation of study treatment.
- •i.Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the enoblituzumab, retifanlimab, or tebotelimab drug formulation.
- •j.Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site.
- •k.History of uncontrolled seizures within 6 months prior to the first dose of study drug.
- •l.Active or history of alcohol or other substance abuse within 1 year prior to the first dose of study drug.
- •8.Clinically significant cardiovascular disease including but not limited to:
- •a.Myocardial infarction or unstable angina within the 6 months prior to the initiation of study drug.
- •b.Stroke or transient ischemic attack within 6 months prior to the initiation of study drug.
- •c.Clinically significant cardiac arrhythmias.
- •d.Uncontrolled hypertension.
- •e.Congestive heart failure.
- •f.Pericarditis or clinically significant pericardial effusion.
- •g.Myocarditis.
- •h.QTcF > 480 milliseconds as the average of 3 repeat examinations.
- •9.Clinically significant gastrointestinal disorders including but not limited to:
- •a.Any history of gastrointestinal perforation unless the affected area has been deemed by the Investigator to no longer be a risk for perforation.
- •b.History of cli
研究者
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