NCT07446322招募中2 期
An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 21
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.
详细描述
Approximately 60 patients will be randomized 1:1 to the following study arms:
- Arm A: FOLFIRI + bevacizumab + pelareorep
- Arm B: FOLFIRI + bevacizumab The primary endpoint is ORR as assessed by the investigator per RECIST 1.1. OS, PFS, and assessment of the safety and tolerability of the study treatment combinations are secondary endpoints. The primary endpoint analysis will be performed after all patients have had at least one tumor assessment following initiation of study treatment or have progressed. The secondary endpoint analyses will take place at EOS.
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
- •Histologically confirmed cancer of the colon or rectum with documented metastasis
- •Measurable disease per RECIST v. 1.1
- •Not candidates for curative surgery or curative radiation
- •Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin
- •Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab
- •Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method
- •Tumor confirmed to harbor a known RAS mutation per a standard local testing method
- •ECOG performance status of 0 or 1
- •Patients must have adequate hematological, renal, and hepatic function
- •Female patients of childbearing potential must have a negative pregnancy test
- •Life expectancy of at least 6 months
排除标准
- •Undergone systemic chemotherapy, radiotherapy, or surgery, <4 weeks before study treatment
- •Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment
- •Prior treatment with irinotecan
- •Symptomatic brain metastases
- •Active autoimmune disease
- •Receiving immunosuppressive or myelosuppressive medications
- •Active, uncontrolled infections
- •Known HIV infection or active hepatitis B or C that requires anti-viral treatment
- •History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ
- •History of allergy or known hypersensitivity to any of the study drugs, study drug classes,
- •Uncontrolled or severe cardiac disease
- •Received any vaccine within 28 days prior to first study treatment
研究组 & 干预措施
Arm A
Experimental
干预措施: Bevacizumab (Drug)
Arm A
Experimental
干预措施: Pelareorep (Drug)
Arm B
Experimental
干预措施: Bevacizumab (Drug)
Arm A
Experimental
干预措施: FOLFIRI (Drug)
Arm B
Experimental
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: At week 8
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
次要结局
- Overall Survival (OS) -(From the date of randomization through long term follow up at two years)
- Progression Free Survival (PFS)(From randomization to objective progression or death from any cause, whichever occurs first, up to two years)
- Disease Control Rate (DCR)(From randomization to disease progression or death from any cause, whichever occurs first, up to two years)
- Duration of Response (DOR)(From randomization to disease progression or death from any cause, whichever occurs first, up to two years)
研究者
研究点 (21)
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