A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
详细描述
AGS-003-005 is a rollover, open label, Phase II clinical study testing the biologic activity and safety of AGS-003 in subjects who have experienced either partial responses or prolonged stable disease and continue to benefit from ongoing treatment with AGS-003 in protocols AGS-003-004 or AGS-003-006.
Rollover subjects from AGS-003-004 will continue with AGS-003 monotherapy booster dosing until disease progression or until a discontinuation criterion is reached.
Subjects that progress on AGS-003 monotherapy (from the AGS-003-004 protocol) may start sunitinib treatment and re-initiate AGS-003 therapy beginning with the induction phase dosing schedule.
Rollover subjects from AGS-003-006 will continue sunitinib dosing in combination with booster dosing of AGS-003 until disease progression or until a discontinuation criterion is reached.
If a subject has disease progression due to a new tumor lesion, upon consultation between the investigator, Argos representatives and the Argos medical monitor, the subject may be considered for re-manufacture of study product (from the new metastatic lesion) and dosing with this new product in combination with sunitinib beginning with the induction phase dosing schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-
- •Measurable disease that can be monitored per RECIST throughout the course of study participation.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate hematologic function, as defined by the following criteria:
- •White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL)
- •Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL)
- •Platelets ≥ 100,000/µL (≥ 100 x 103/µL)
- •Hemoglobin (Hgb) ≥ 9.0 g/dL
- •Adequate renal and hepatic function, as defined by the following criteria:
- •Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or, if serum creatinine > 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
- •Total serum bilirubin ≤ 1.5 x ULN
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
- •Adequate coagulation function as defined by the following criteria:
- •Prothrombin time (PT) ≤ 1.5 x ULN
- •Activated partial thromboplastin time (PTT) < 1.5 x ULN
- •Corrected calcium ≤ 11.5 mg/dL
- •Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
- •Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- •No brain metastases detected by magnetic resonance imaging (MRI).
排除标准
- •Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment
- •History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
- •Pregnancy or breastfeeding
- •Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- •NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
研究组 & 干预措施
AGS-003 in combination with sunitinib
Subjects will undergo Induction (AGS-003 every 3 weeks until 5 doses are administered) followed by Booster (AGS-003 at 3 month intervals). Subjects that will begin sunitinib therapy will be on this arm.
干预措施: AGS-003 (Drug)
结局指标
主要结局
Tumor response
时间窗: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
次要结局
- Immune function(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Overall Survival (OS)(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Monitor signs and symptoms indicating treatment-emergent autoimmunity(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Monitor for lymph node adenopathy(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Injection Site Reaction(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Clinical benefit (stable disease or response)(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Progression Free Survival (PFS)(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Treatment-emergent Adverse Events(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Monitor clinical chemistry, hematology, and urinalysis for treatment-emergent changes from baseline(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Physical Examinations(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Vital Signs(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)