A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Phase I: Recommended Phase II Dose
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.
详细描述
This study has two parts and participants may be involved in either Phase I part or Phase II.
Phase I: Investigators plan to enroll participants in cohorts of 6 and monitor side effects over a 21 day period to determine the maximum tolerated dose (MTD) of nivolumab, which will be given in combination with GM.CD40L. This is being done since this study involves a combination of treatments that have not been studied in humans before and to find the best dose for the Phase II part of the study.
Phase II: Investigators plan to compare any clinical benefit in the participants who receive the combination of GM.CD40L vaccine with nivolumab, to participants that receive only nivolumab.
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
- •Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
- •Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (NSCLC) >6 months prior
- •Adequate bone marrow, renal and hepatic function
- •Must have measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
- •Mandatory archival tissue or willingness to undergo a fresh biopsy
- •Life expectancy of greater than 6 months
排除标准
- •Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis
- •Pregnancy or breast feeding
- •Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment
- •Prior use of a PD1 or PDL1 inhibitor
- •Concurrent use of other anticancer approved or investigational agents is not allowed
- •Autoimmune disorders
- •Prior malignancy in past 2 years
- •Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent
- •Any other pre-existing immunodeficiency condition (including known HIV infection)
研究组 & 干预措施
Phase I and Phase II Treatment Arm
Participants will receive nivolumab and GM.CD40L. Treatment will be administered on an outpatient basis. The nivolumab will be given first followed by the GM.CD40L vaccine for those enrolled on this arm.
干预措施: Nivolumab (Drug)
Phase I and Phase II Treatment Arm
Participants will receive nivolumab and GM.CD40L. Treatment will be administered on an outpatient basis. The nivolumab will be given first followed by the GM.CD40L vaccine for those enrolled on this arm.
干预措施: GM.CD40L Vaccine (Biological)
Phase II Control Arm
Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Phase I: Recommended Phase II Dose
时间窗: Up to 2 months
The recommended Phase II dose will be defined as the highest dose level of GMCD40L vaccine in combination with nivolumab that induced dose limiting toxicity (DLT) in fewer than 33% of patients.
Phase II: Objective Response Rate (ORR)
时间窗: Up to 2 years
Objective tumor response per treatment arm. ORR: Complete Response (CR) = disappearance of all target lesions + Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
次要结局
- Phase II: Overall Survival (OS)(Up to 2 years)
- Phase II: Progression-free Survival (PFS)(Up to 2 years)