A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors

Merck Sharp & Dohme LLC0 个研究点目标入组 37 人开始时间: 2008年8月1日最近更新: 2015年3月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 37
主要终点: Number of Participants With Dose-Limiting Toxicity (DLT)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.

详细描述

Two vaccines will be administered: V934-electroporation (EP) either low dose (LD) or high dose (HD), and V935 either LD or HD. In Part A, participants will be assigned to V935 vaccine alone or in combination with V934-EP. Part B will be an optional part of the study, offering V934-EP vaccine booster to participants who were enrolled in Part A.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

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

•Participant has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Selected Solid Tumors: Stage I to III non-small cell lung carcinoma (NSCLC); Stage III breast cancer; Stage IIB or III melanoma; Stage II or III upper gastrointestinal tract carcinoma (e.g., esophagus, stomach, gallbladder, pancreas); Stage III colon carcinoma; Stage II, III, or IV (M0 only) renal cell carcinoma; Stage II, III, or IV (M0 only) bladder carcinoma; clinically-localized prostate carcinoma
•Participant has adequate organ function.
•Female participant of childbearing potential has a negative serum pregnancy test within 3 days of study enrollment.

排除标准

•Participant has known hypersensitivity to any component of study vaccine.
•Participant has a history of clinically significant cardiac conditions, including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or New York Heart Association (NYHA) Class III or IV congestive heart failure. Participant must have no clinically significant electrocardiogram (ECG) abnormalities and not have a pacemaker or cardioverter/defibrillator implanted.
•Participant has undergone splenectomy or has any history of autoimmune disorder.
•Participant has received immunosuppressive treatment within 1 month prior to enrollment.
•Participant has known acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections.
•Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of study entry.
•Participant is pregnant or breastfeeding, or expecting to conceive at any time during the study or within 1 year after receiving the last vaccination.
•Participant is known to be Human Immunodeficiency Virus (HIV)-seropositive.
•Participant has known history of Hepatitis B or C or active Hepatitis A.
•Participant has been vaccinated for any disease or for prophylaxis within 1 month prior to the first vaccination.
•The participant has been diagnosed with Systemic Lupus Erythematosus (SLE)
•Inclusion Criteria Part B
•Participant must have completed their respective vaccination Treatment Group regimen for Part A of this study.
•Participant must have completed a ≥12 week safety observation period prior to receiving their first V934-EP boost.
•Exclusion Criteria Part B
•Participant has new or metastatic tumor lesions since enrollment in Part A.
•Participant has developed any significant cardiac conditions since enrollment in Part A including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or NYHA Class III or IV congestive heart failure.
•Participant has undergone a splenectomy, or has developed any autoimmune disorders, since enrollment in Part A.
•Participant has received immunosuppressive treatment within 1 month prior to enrollment in Part B
•Participant has developed any acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections
•Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of entry to Part B.

研究组 & 干预措施

Part A: V934 LD(3)+V935 LD

Experimental

Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period.