ACTRN12609000099224进行中（未招募）3 期
GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma to Assess Disease Free Survival
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Written informed consent signed.
- •Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
- •The patient must have been surgically rendered free of disease before the randomization.
- •Patient is = 18 years old at the time of signing the informed consent form.
- •The patient's lymph node tumor shows expression of the MAGE-A3 gene.
- •The patient has fully recovered from surgery.
- •ECOG performance status of 0 or 1 at the time of randomization.
- •The patient must have adequate organ functions as assessed by standard laboratory criteria.
- •If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
- •In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.
排除标准
- •The patient suffers from melanoma of non-cutaneous origin.
- •The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
- •The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
- •The patient has a history of autoimmune disease.
- •The patient has a family history of congenital or hereditary immunodeficiency.
- •The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
- •History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
- •The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
- •The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- •The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- •The patient has an uncontrolled bleeding disorder.
- •For female patients: the patient is pregnant or lactating.
研究者
相似试验
未知
Unknown
GSK2132231A Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resected melanomamelanomaJPRN-jRCT2080221174GlaxoSmithKline K.K.
未知
3 期
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Canceron-Small Cell Lung CancerJPRN-jRCT2080220584GlaxoSmithKline K.K.
终止
3 期
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their TumorMelanomaNCT00796445GlaxoSmithKline1,351
已完成
2 期
A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced MelanomaMelanomaNCT00942162GlaxoSmithKline125
终止
3 期
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung CancerLung Cancer, Non-Small CellNCT00480025GlaxoSmithKline2,278