EUCTR2014-003863-40-IT进行中（未招募）1 期
A Phase III Randomized, Open-Label, Multi-Center, Global Study ofMEDI4736 Monotherapy and MEDI4736 in Combination with TremelimumabVersus Standard of Care Therapy in Patients withRecurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck(SCCHN) - NA
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
- 736
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,
- •3. Histologically confirmed recurrent or metastatic SCCHN 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 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 lymphnodes 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. 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 screening11. 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 age-specific requirements apply
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
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
- •XML File Identifier: C2NBg2kHOfcVbVKXB+QtFy9vMBc=
- •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 Investig
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of Durvalumab(MEDI4736) in combination with intravesical BCG for the treatment of patients diagnosed with early stage bladder cancer (non-muscle invasive) compared to the standard therapy of intravesical BCG alone.on-muscle invasive bladder cancerCTIS2023-505341-23-00AstraZeneca AB1,026
进行中（未招募）
1 期
Study of MEDI4736 with or without Tremelimumab Versus standard ofcare chemotherapy in lung cancer (MYSTIC Study)Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naiive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology.MedDRA version: 18.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864EUCTR2015-001279-39-FRAstraZeneca AB675
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of Durvalumab (MEDI4736) in combination with intravesical BCG for the treatment of patients diagnosed with early stage bladder cancer (non-muscle invasive) compare to the standard therapy of intravesical BCG alone.on-muscle invasive bladder cancerMedDRA version: 20.0Level: PTClassification code 10005008Term: Bladder cancer stage I, with cancer in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-002979-26-FRAstraZeneca AB975
进行中（未招募）
1 期
Study of Durvalumab with Tremelimumab Versus standard of care chemotherapy in lung cancer (NEPTUNE Study).EUCTR2015-002197-21-GRAstraZeneca AB1,330
进行中（未招募）
1 期
Study of MEDI4736 monotherapy and MEDI4736 in combination with Tremelimumab versus Standard of Care Therapy in patients with SCCHRecurrent or metastatic PD-L1-positive or negative squamous cell carcinoma of the head and neck (SCCHN).MedDRA version: 18.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-003863-40-ROAstraZeneca AB736