Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 19
- 主要终点
- Summary of Disease Progression in Study Participants, Intent-to-treat Population
研究概览
简要总结
Primary objective:
To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment.
Secondary objectives:
Safety: To describe the safety profile in both treatment groups.
Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
详细描述
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography [CT] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases.
- •Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression.
- •Aged ≥ 18 years on the day of inclusion
- •IRB-approved informed consent form signed
- •Able to attend all scheduled visits and to comply with all trial procedures
- •For a woman, inability to bear a child or negative serum pregnancy test
- •For a woman of child-bearing potential, using an effective method of contraception or abstinence during the study and at least 4 weeks after the last study treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
- •Adequate hematologic, hepatic, and renal function (at pre-defined laboratory values).
- •Fully recovered from surgery, if applicable.
排除标准
- •Receipt of two or more previous therapies for metastatic melanoma.
- •Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks
- •Receipt of adjuvant interferon therapy within the last six months
- •Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes
- •Participation in another clinical trial within the four weeks preceding the first trial treatment
- •Planned participation in another clinical trial during the present trial period
- •Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or hepatitis C seropositivity
- •Presence of active autoimmune disease (excluding vitiligo)
- •Systemic hypersensitivity to bovine products or to any of the vaccine components, including egg products or Neomycin (used to prepare the vaccine), or history of a life-threatening reaction to granulocyte-macrophage colony stimulating factor (GM-CSF) or interferon (IFN)-α2b
- •Current alcohol or drug addiction that may interfere with the ability to comply with trial procedures
- •Significant co-morbid medical conditions, including pre-existing renal disease, cirrhosis, or major depression, which in the estimation of the investigator would preclude safe participation in the study or the accurate interpretation of data.
- •A calculated glomerular filtration rate (GFR) <60 mL/min (based on the Cockroft-Gault formula).
- •Previous receipt of a modified canarypox virus (ALVAC)-based vaccine.
研究组 & 干预措施
Study Group 1: ALVAC melanoma vaccine
Participants will receive a multi-antigen of modified canarypox virus (ALVAC[2]) melanoma vaccine and granulocyte macrophage colony stimulating factor (GM-CSF) every 3 weeks, followed by 4 weeks of high-dose interferon alpha-2b 5 times per week.
干预措施: ALVAC(2) Melanoma multi-antigen therapeutic vaccine (Biological)
Study Group 2: Interferon alpha-2b
Participants on 4 weeks of high-dose interferon alpha-2b 5 times per week. Participants who showed disease progression after Cycle 1 will be permitted to cross over to Group 1 treatment.
干预措施: Intron A, Interferon alpha -2b (Biological)
结局指标
主要结局
Summary of Disease Progression in Study Participants, Intent-to-treat Population
时间窗: Day 0 up to 35 weeks post 1st vaccination or treatment
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography \[CT\] scans or physical examination).
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
时间窗: Day 0 - up to 35 weeks post 1st vaccination or treatment
Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
次要结局
- Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population(Day 0 to 32 weeks post 1st vaccination or treatment)
- Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population(Day 0 to 32 weeks post 1st vaccination or treatment)
- Best Overall Objective Response in the Intent-to-treat Population(Day 0 to 32 weeks post 1st vaccination or treatment)
- Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term(Day 0 to 12 months post last vaccination)