EUCTR2015-003011-38-GB进行中（未招募）1 期
A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in combination with Pembrolizumab for theTreatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Amgen Inc.0 个研究点目标入组 490 人开始时间: 2015年10月19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
- 490
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
- •Male or female age = 18 years with histologically confirmed diagnosis
- •of metastatic or recurrent SCCHN of the oral cavity, oropharynx,
- •hypopharynx, or larynx. Disease must be unsuitable for curative surgical
- •resection and must not be amenable to curative radiotherapy.
- •Disease must have progressed after treatment with a platinumcontaining
- •Subject must be candidate for intralesional therapy administration
- •defined as one or more of the following:
- •- At least 1 injectable cutaneous, subcutaneous, or nodal SCCHN tumor =
- •10 mm in longest diameter
- •- Multiple injectable cutaneous, subcutaneous, or nodal SCCHN tumors
- •that in aggregate have a longest diameter of = 10 mm
- •Subject must have radiographically measurable disease
- •ECOG performance status of 0 or 1
- •Adequate organ function determined within 14 days prior to
- •PTT or aPTT = 1.5 x ULN unless the subject is receiving anticoagulant
- •therapy as long as PT and PTT/aPTT is within therapeutic range of
- •intended use of anticoagulants. Female subject of childbearing potential
- •must have a negative pregnancy test within 72 hours prior to
- •enrollment. If urine pregnancy test is positive or cannot be confirmed as
- •negative, a serum pregnancy test will be required.
- •Phase 1b: Subject has a formalin fixed paraffin-embedded tumor
- •sample (within 6 months prior to week 0, day 1 of the study, or newly
- •obtained biopsy) from the primary or metastatic lesion that must be
- •submitted within 4 weeks of enrollment for PD-L1, HPV-testing of
- •oropharyngeal cancer (if not performed locally) and biomarker analyses.
- •Phase 3: Subject has a tumor sample and no systemic therapy given
- •since the biopsy or newly obtained biopsy from the primary or
- •metastatic lesion that is adequate for PD-L1 assessment prior to
- •randomization
- •Phase 3: Have results from local testing of HPV of tumor specimen for
- •oropharyngeal cancer defined as p16 IHC testing using the CINtec®
- •assay and a 70% cutoff point
- •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 392
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis, primary nasopharyngeal carcinoma
- •Subject at risk of airway compromise in the event of postinjection tumor swelling/inflammation based on investigator judgment
- •Greater than three lines of prior therapy for current malignancy and/or metastatic disease (Phase 3)
- •History of other malignancy within the past 3 years, evidence of active, non-infectious pneumonitis, history of interstitial lung disease (ILD)
- •Prior therapy with talimogene laherparepvec, pembrolizumab, other anti-PD-1, any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathway
- •History or evidence of active autoimmune disease that has required systemic treatment in past 2 years, evidence of clinically significant immunosuppression
- •Prior or active herpetic infection, require treatment with an antiherpetic drug, other than intermittent topical use
- •Prior cancer therapy, targeted therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
- •Has a history of (non-infectious) pneumonitis that required steroids or
- •current pneumonitis.
- •Subjects with tumor that directly contacts or encases a major blood
- •vessel AND there is ulceration and/or fungation onto the skin surface.
- •History of re-irradiation to a field which includes the carotid arteries.
研究者
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