Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage Ilc, Illb, lIIc, or IV Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 15
- 主要终点
- Rate of Relapse-free Survival at 18 Months
研究概览
简要总结
The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.
详细描述
NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for participants with Malignant Melanoma which has been removed, but is at high risk of recurrence.
Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).
Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically proven malignant melanoma.
- •Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
- •Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
- •Within six months of surgery for melanoma.
- •Full recovery from surgery.
- •No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and resected after this.)
- •Age 18 years or older.
- •Able to give written informed consent.
- •Vital laboratory parameters within normal range, or protocol specified ranges.
排除标准
- •Other serious or significant illnesses.
- •Resected cerebral metastases.
- •Ocular melanoma.
- •Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ.
- •Using immunosuppressive drugs.
- •Anticoagulation.
- •Known HIV positivity.
- •Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
- •Not available for immunological and clinical follow-up assessments.
- •Participation in prior clinical trial involving an investigational agent within last 4 weeks.
- •Previous isolated limb perfusion (ILP).
- •Pregnancy or breastfeeding.
- •Refusal or inability to use effective means of contraception for women of childbearing potential.
- •Mental impairment that may compromise ability to give informed consent and to comply with study requirements.
研究组 & 干预措施
Vaccine
NY-ESO-1 ISCOMATRIX® vaccine
干预措施: NY-ESO-1 ISCOMATRIX® (Biological)
Adjuvant Alone
ISCOMATRIX® adjuvant alone
干预措施: ISCOMATRIX® adjuvant (Biological)
结局指标
主要结局
Rate of Relapse-free Survival at 18 Months
时间窗: 18 months
The number of patients who were alive and relapse free 18 months after starting therapy and the number of patients who relapsed or died within 18 months of starting therapy. Disease was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) as measured by CT. Disease progression or relapse was based on an increase of 20% or more in the sum of the longest diameter of target lesions, the appearance of any new lesion as confirmed by CT scan or death.
次要结局
- Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).(through study completion; up to 6 years)
- NY-ESO-1 Antibody Response on Day 71 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response(Day 71)
- Number of Patients With Treatment -Emergent Adverse Events (TEAEs)(18 months)
- Overall Survival(through study completion; up to 6 years)
- NY-ESO-1 Antibody Response at Baseline Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response(Baseline)
- NY-ESO-1 Antibody Response on Day 197 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response(Day 197)
- NY-ESO-1 Antibody Response at End of Study Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response(End of Study (month 18))
- NY-ESO-1 Antibody Response on Day 365 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response(Day 365)