A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented mismatch repair-proficient cancer of colorectum, who have received at least two prior lines of therapy for metastatic disease
- •Measurable disease by RECIST v1.1
- •Age >18 years
- •ECOG Performance Status of 0 to 1
- •Estimated life expectancy of greater than 3 months.
- •Adequate organ function as defined by study-specified laboratory tests
- •Must use acceptable form of birth control through the study and for 120 days after final dose of study drug
- •Signed informed consent form
- •Willing and able to comply with study procedures
排除标准
- •Has a known additional malignancy that is progressing or requires active treatment.
- •Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has known malignant small bowel obstruction within the last 6 months.
- •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- •Systemically active steroid use.
- •Has an active infection requiring systemic therapy.
- •Has a known history of active TB (Bacillus Tuberculosis).
- •Infection with HIV or hepatitis B or C.
- •Has history of (non-infectious) pneumonitis that required steroids.
- •Must not require supplemental oxygen or have a pulse oximetry < 92% on room air.
- •Conditions, including therapy, laboratory abnormalities, psychiatric or substance abuse disorders, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
- •Pregnant or lactating.
- •Another investigational product within 28 days prior to receiving study drug.
- •Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
- •Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug.
- •Has received a live vaccine within 30 days of planned start of study therapy.
- •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- •Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
- •Hypersensitivity to pembrolizumab or any of its excipients.
- •Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX vaccine.
- •Presence of any tissue or organ allograft and history of allogeneic hematopoietic stem cell transplant.
- •Unwilling or unable to comply with study procedures.
研究组 & 干预措施
CY/GVAX with Pembrolizumab
During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells for the first 4 cycles of treatment. After cycle 4, cyclophosphamide and GVAX will be administered with every 4th cycle.
干预措施: CY (Drug)
CY/GVAX with Pembrolizumab
During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells for the first 4 cycles of treatment. After cycle 4, cyclophosphamide and GVAX will be administered with every 4th cycle.
干预措施: GVAX (Biological)
CY/GVAX with Pembrolizumab
During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells for the first 4 cycles of treatment. After cycle 4, cyclophosphamide and GVAX will be administered with every 4th cycle.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 1 year
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
次要结局
- Progression Free Survival (PFS)(up to 1 year)
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(up to 1 year)
- Duration of Response (DOR)(1 year)
- Overall Survival (OS)(Up to 1 year)