GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 40
- 主要终点
- Time to Occurrence of Any Recurrence of Disease
研究概览
简要总结
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.
Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. The participants were no longer enrolled in the study, the follow ups on subjects were stopped and the collection and analysis of samples for further research purposes was stopped.
After the stop to recruitment, the study was unblinded, as per the amended protocol, the study treatment was continued and completed with the subjects of the active treatment group who were willing to continue. Subjects in the placebo group were withdrawn.
There was no longer an active follow-up of patients after discontinuation or completion of the treatment. The study ended 30 days after the last dose was administered.
As a result, primary and secondary objectives were not assessed as planned. All clinical and safety data collected in the study were analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing was not performed by default, except if a scientific rationale remained relevant despite the premature termination of the study.
详细描述
During the treatment period, safety monitoring continued as initially foreseen. Reporting of post-study adverse events (AEs) and serious AEs (SAEs) continued as per protocol. In the best interest of the patient, no more biological samples for protocol research purposes (i.e. serum sampling for humoral immunity, whole blood sampling for pharmacogenetics) were taken.
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
- •The patient has radically resected NSCLC
- •The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy The patient's tumor shows expression of PRAME.
- •The patient is ≥ 18 years of age at the time of first consent.
- •Written informed consent has been obtained from the patient prior to performance of any study-specific procedure.
- •The patient is free of disease (no residual tumor, no loco-regional recurrence, no distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be performed as clinically indicated.
- •Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 at the time of randomization
- •Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessed by standard laboratory criteria
- •If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study product, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after last treatment administration.
- •Patients who the investigator believes can and will comply with the requirements of this protocol (e.g. return for active follow-up visits).
排除标准
- •The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years. Patients with effectively treated non - melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of which in remission for less than 5 years will be eligible.
- •The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except for:
- •Administration of adjuvant platinum-based doublet chemotherapy for the treatment of the current NSCLC allowed between surgery and randomization.
- •Treatment of previous malignancies as allowed by the protocol.
- •The patient has been diagnosed with a Potential Immune-Mediated Disease (pIMD). Patients with vitiligo are not excluded from the study.
- •The patient has a history of confirmed adrenal dysfunction.
- •The patient requires concomitant treatment with any immunosuppressive agent, or with systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive days).
- •The patient needs chronic long term oxygen therapy (LTOT). The patient has medically uncontrolled congestive heart failure or hypertension, unstable heart disease or uncontrolled arrhythmia at the time of randomization.
- •The patient has an uncontrolled bleeding disorder.
- •The patient has undergone splenectomy.
- •The patient is known to be Human Immunodeficiency Virus (HIV)-positive.
- •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 other 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 a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- •The patient has received any investigational or non-registered product within the 30 days preceding randomization, or planned use during the study period.
- •For female patients: the patient is pregnant or lactating or is planning to become pregnant.
研究组 & 干预措施
GSK2302032A Group
The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
干预措施: Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A (Biological)
Placebo group
The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
干预措施: Placebo (Biological)
结局指标
主要结局
Time to Occurrence of Any Recurrence of Disease
时间窗: During the entire study (From Week 1 to Week 112)
Time to occurrence of any recurrence of disease was expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T\[year)\]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies.
次要结局
- Lung-cancer-specific Survival(During the entire study (From Week 1 to Week 112))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) post-vaccine administration period)
- Overall Survival (OS)(During the entire study (From Week 1 to Week 112))
- Disease-free Specific Survival (DFSS)(During the entire study (From Week 1 to Week 112))
- Number of Subjects With Any Abnormal Hematological and Biochemical Parameters(During the entire study period (From Week 1 to Week 112))
- Number of Subjects With Any Serious Adverse Events (SAEs)(During the entire study (From Week 1 to Week 112))
- DFS (Disease-free Survival) at 2, 3, 4 and 5 Years After Randomization(During the entire follow-up period (From year 2 to Year 5))
- Anti-PRAME Antibody Concentrations(At each defined time point from Week 0 till Concluding Visit (Week 112))
- Number of Subjects With Any Adverse Events (AEs) by Intensity Grade.(From Week 0 to Week 112)