Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 17
- 主要终点
- Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
研究概览
简要总结
This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
详细描述
CONSORTIUM-IO was the first-in-human multicenter, open-label study; the main objectives were to evaluate:
- Safety and tolerability of VE800 in combination with nivolumab
- Efficacy as measured by objective response rate
The study planned to enroll approximately 111 patients with melanoma, gastric/gastroesophageal junction (GEJ) adenocarcinoma, or microsatellite-stable (MSS) colorectal cancer (CRC).
Nivolumab is already approved by the U.S. Food and Drug Administration (FDA), however, it is not approved for the study cancer indications. VE800 was the investigational product, which was designed to enhance the immune response to the tumor.
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
- •Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease.
- •Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1
- •Tumor lesions amenable for biopsy, if deemed safe by the investigator
- •Toxicity from prior cancer therapy should have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed)
排除标准
- •Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma)
- •Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin
- •Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis.
- •Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
- •Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll.
- •Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C were permitted to enroll if there was evidence of documented resolution of infection.
- •Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800
研究组 & 干预措施
VE800 combination treatment with nivolumab
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
干预措施: VE800 (Biological)
VE800 combination treatment with nivolumab
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
干预措施: Nivolumab (Drug)
VE800 combination treatment with nivolumab
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
干预措施: Vancomycin Oral Capsule (Drug)
结局指标
主要结局
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
时间窗: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up
Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events
Objective Response Rate (ORR)
时间窗: 18 months (first patient enrolled to last patient visit completed)
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Duration of Response (DOR)(Up to two years)
- Overall Survival (OS)(18 months (first patient enrolled to last patient visit completed))
- Detection of VE800 Bacterial Strain Colonization in Stool(18 months (first patient enrolled to last patient visit completed))
- Degree of VE800 Bacterial Strain Colonization in Stool(18 months (first patient enrolled to last patient visit completed))
- Duration of VE800 Bacterial Strain Colonization in Stool(18 months (first patient enrolled to last patient visit completed))
- Best Overall Response(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Progression-Free Survival (PFS)(From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days.)