NCT03089658Approved For Marketing不适用
Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 1
研究概览
简要总结
Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measurable metastatic Merkel cell carcinoma according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), has failed at least one line of adequately dosed chemotherapy in the metastatic setting and has subsequently progressed (where adequate dosing is defined as a minimum of 2 cycles)
- •Not eligible for participation in any ongoing clinical trial for Merkel cell carcinoma including the Javelin Merkel 200 study (NCT02155647)
- •Adequate hematological, hepatic and renal function as defined in the protocol
排除标准
- •Brain metastases
- •Prior organ transplantation, including allogeneic stem cell transplantation
- •History of testing positive for human immunodeficiency virus (HIV) or known AIDS or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Concurrent, active, malignant disease (other than Merkel cell carcinoma) with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ as defined in protocol
- •Previous or active autoimmune disease requiring systemic immunosuppressive therapy
- •Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
- •Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident / stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment) unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication
- •Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03 (alopecia and sensory neuropathy Grade ≤ 2 is acceptable)
- •Being treated with chronic systemic corticosteroids or other chronic therapeutic immunosuppression
- •Pregnant or lactating (for women of childbearing potential)
- •Not using a highly effective contraception if the risk of conception exists
研究者
研究点 (1)
Loading locations...
相似试验
No Longer Available
不适用
Flotetuzumab Expanded Access ProgramAcute Myeloid LeukemiaAML, Adult RecurrentAMLNCT04678466MacroGenics
Approved For Marketing
不适用
Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNCT04599712Janssen Research & Development, LLC
Available
不适用
Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDSMyelodysplastic SyndromesAcute Myeloid LeukemiaNCT05593185Sellas Life Sciences Group
Approved For Marketing
不适用
An Expanded Access Program of Emicizumab in Participants With Hemophilia A With InhibitorsHemophilia ANCT03154437Genentech, Inc.
No Longer Available
不适用
Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)Multiple MyelomaNCT05238311Pfizer