A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Agenus Inc.
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation)
研究概览
简要总结
This is an international, open label, randomized phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with autologous HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.
详细描述
This is an international, open label, randomized Phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.
The primary objective of the study is to determine whether patients who receive adjuvant autologous HSPPC-96 (treatment group) after surgical resection of locally advanced renal cell carcinoma have improved recurrence-free survival as compared to patients who are not receiving adjuvant treatment (observation group). Eligible patients will have a 50% chance of receiving adjuvant treatment with HSPPC-96. Patients in the treatment arm of the trial will receive the vaccine once a week for 4 weeks, and then every other week until vaccine depletion or disease recurrence. Both groups of patients will be followed regularly for assessment of their disease status.
HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •This does not represent the full set of inclusion/
排除标准
- •Inclusion Criteria:
- •Patients must have primary-intact resectable renal cell cancer, without distant metastasis and be scheduled to have surgery with curative intent
- •Tumor size > 5 cm OR macroscopic nodes OR vena cava thrombus by radiologic evaluation
- •At least 18 years old
- •Signed informed consent
- •Exclusion Criteria:
- •Prior surgery, chemo-, hormonal-, immuno-, or radiotherapy for kidney cancer
- •History of other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin
- •Current malignancies of any type in other sites
- •No active uncontrolled infection, other serious medical illnesses, or splenectomy
- •History of primary or secondary immunodeficiencies
结局指标
主要结局
To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation)
次要结局
- To determine whether patients randomized to receive adjuvant HSPPC-96 have improved overall survival as compared to patients in the observation group (without adjuvant treatment)
- To further characterize the safety profile of HSPPC-96