A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Therapy in Patients withRecurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

AstraZeneca AB0 个研究点目标入组 736 人开始时间: 2015年10月26日最近更新: 2022年1月17日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 736

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

•1. Age =18 years at the time of screening
•2. Written informed consent and any locally required authorization obtained from the patient/legal
•representative prior to performing any protocol-related procedures, including screening evaluations. (For patients aged <20 years and enrolling in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.)
•3. Histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Patients who refuse radical resection are eligible.
•4. Tumor progression or recurrence during or after treatment with 1 regimen for recurrent or metastatic disease that must have contained platinum OR progression within 6 months from multimodality therapy containing platinum (for either locally advanced disease or recurrent/metastatic disease)
•5. Able and willing to give valid written consent to undergo a fresh tumor biopsy for the purpose of screening for this clinical trial or to provide an available archival tumor sample taken less than 3 months ago if a fresh tumor biopsy is not feasible with an acceptable clinical risk. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
•6. Confirmed PD-L1-positive or -negative SCCHN by a specified IHC assay on a recent sample (<3 months) or fresh tumor biopsy
•7. WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
•8. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as =10 mm in the longest diameter (except lymph nodes which must have a short axis =15 mm) with CT or MRI and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. Lesions in a previously irradiated field can be used as measurable disease provided that there has been demonstrated progression in the lesion.
•9. Patients must have no prior exposure to immune-mediated therapy, including other anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines. Exposure to other investigational agents may be permitted after discussion with the Sponsor.
•10. Adequate organ and marrow function independent of transfusion for at least 7 days prior to Screening and independent of growth factor support for at least 14 days prior to screening, defined as:
•? -Hemoglobin =9 g/dL
•? -Absolute neutrophil count =1500/mm3
•? -Platelet count =100000/mm3
•? -Serum bilirubin =1.5 × the ULN. This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician.
•? - ALT and AST =2.5 × ULN; for patients with hepatic metastases, ALT and AST
•? - Calculated creatinine clearance >40 mL/min as determined by Cockcroft-Gault
•(using actual body weight)
•11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
•The following age-specific requirements apply:
•? -Women <50 years of age would be considered post-menopaus

排除标准

•1. Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck not specified in the inclusion criteria, patients with SCCHN of unknown primary, and nonsquamous
•histologies 2. Received more than 1 regimen for recurrent or metastatic disease 3. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal
•therapy for non-cancer-related conditions is acceptable. 4.Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment. Receipt of
•last dose of an approved anticancer therapy within 21 days prior to the first dose of study treatment. If sufficient washout time has not occurred due to the schedule or PK properties of an agent, a longer washout
•period will be required, as agreed upon by AZ and the Investigator. 5. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. 6. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia and the laboratory values defined in the inclusion criterion (i) Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis and may be included after consultation with the Study Physician. (ii) Patients with a toxicity not reasonably expected to be exacerbated by treatment with their assigned IP may be included after consultation with the Study Physician. 7. Current or prior use of immunosuppressive medication within 14 days before the first dose of
•their assigned IP. 8. History of allogeneic organ transplantation 9. Active or prior documented autoimmune or inflammatory disorders (including colitis, Crohn's disease,diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, or other serious GI chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis; uveitis, etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: (i) Patients with vitiligo or alopecia; (ii) Patients with hypothyroidism stable on hormone replacement or psoriasis not requiring systemic treatment 10.
•Uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial
•lung disease, or psychiatric illness or social situations that would limit compliance with study requirements, substantially increase the risk of incurring AEs from IP, or compromise the ability of the patient to give written informed consent 11.History of another primary malignancy except for (i) Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drug and of low
•potential risk for recurrence (ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (iii) Adequately treated carcinoma in situ without evidence of disease e.g. cervical cancer
•in situ 12. Patients with history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, or involvement of any other anatomic area that, in the opinion of the Investigator, may cause significant symptoms if an inflamma

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发起方

AstraZeneca AB

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