NCT05968326进行中（未招募）2 期
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 300
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.
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 diagnosis of PDAC
- •Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
- •Macroscopically complete (R0 or R1) resection of PDAC
- •Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to treatment initiation
- •CA19-9 level measured within 14 days prior to initiation of study treatment
- •Interval of between 6 and 12 weeks since resection of PDAC
- •Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
- •Adequate hematologic and end-organ function
- •Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 28 days after the final dose of autogene cevumeran, for 9 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. They must refrain from donating eggs for 9 months after the last dose of chemotherapy.
- •Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.
排除标准
- •Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
- •Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment
- •Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
- •Preexisting Grade >/=2 neuropathy
- •Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency
- •Disorders of the colon or rectum, or postoperative complication leading to Grade >/=2 diarrhea
- •Pregnancy or breastfeeding
- •Active or history of autoimmune disease or immune deficiency
- •Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment
- •Current or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).
研究组 & 干预措施
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Experimental
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
干预措施: Atezolizumab (Drug)
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Experimental
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
干预措施: mFOLFIRINOX (Drug)
Arm 2: mFOLFIRINOX
Active Comparator
Participants will receive mFOLFIRINOX.
干预措施: mFOLFIRINOX (Drug)
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Experimental
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
干预措施: Autogene cevumeran (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years
次要结局
- Overall Survival (OS)(From randomization to death from any cause (up to approximately 6 years))
- OS Rates at 3 and 5 Years(Years 3 and 5)
- Percentage of Participants With Adverse Events (AEs)(Up to approximately 6 years)
- DFS Rates at 12, 24, and 36 Months(Months 12, 24, 36)
研究者
研究点 (300)
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相关资讯
BioNTech Terminates Phase 2 Trial of Autogene Cevumeran in Resected Colorectal Cancer- BioNTech and Genentech have decided to terminate the Phase 2 BNT122-01 trial (NCT04486378) of autogene cevumeran as adjuvant monotherapy in ctDNA-positive, resected Stage II/III colorectal cancer.
- The decision follows a Data Safety Monitoring Board recommendation citing a numerical imbalance in overall survival and low likelihood that further continuation would change the efficacy outcome.
- No new safety signals were identified for autogene cevumeran, and the parallel Phase 2 IMcode003 trial in adjuvant pancreatic ductal adenocarcinoma continues as planned.
- BioNTech will conduct a thorough analysis of trial data to inform patient selection and the future development of investigational mRNA cancer immunotherapies.22 days agoNanomedicine Strategies for Remodeling the Solid Tumor Microenvironment: Stromal Targeting, Hypoxia Modulation, and Photodynamic Immunotherapy- A comprehensive review in Frontiers in Oncology outlines how nanomedicine can remodel the solid tumor microenvironment through stromal targeting, hypoxia control, and photodynamic immune activation.
- Cancer-associated fibroblasts, dense extracellular matrix, hypoxia, and immunosuppressive myeloid and lymphoid populations jointly limit drug delivery and treatment response in solid tumors.
- The authors argue that biomarker-guided, mechanism-matched platforms with measurable microenvironmental endpoints—rather than ever-greater carrier complexity—offer the most realistic path to clinical translation.
- Failed phase III trials such as HALO-301 and MAESTRO underscore that plausible stromal or hypoxia mechanisms do not guarantee survival benefit without validated spatial biomarkers and target-engagement measures.2 months agoTherapeutic Cancer Vaccines Show Promise for Pancreatic Cancer Treatment Despite Immunosuppressive Challenges- Pancreatic cancer vaccines utilizing dendritic cells, whole tumor cells, and nucleic acid platforms demonstrate encouraging clinical results, with WT1-DC vaccines combined with chemotherapy showing significant survival improvements in advanced PDAC patients.
- Novel mRNA neoantigen vaccine autogene cevumeran induced lasting T cell responses for up to three years and delayed PDAC recurrence in adjuvant settings, with a global randomized trial currently underway.
- Despite promising early results, pancreatic cancer's low mutational burden, immunosuppressive tumor microenvironment, and technological challenges in vaccine development remain significant obstacles requiring combination therapeutic strategies.11 months agoNCT/UCC Dresden Launches Phase 2 Trial of Personalized mRNA Vaccine for Pancreatic Cancer- NCT/UCC Dresden becomes the only site in Saxony to offer patients access to BioNTech and Genentech's personalized mRNA vaccine Autogene Cevumeran for pancreatic cancer treatment.
- The Phase 2 IMCODE003 study combines the mRNA vaccine with checkpoint inhibitor Atezolizumab and chemotherapy to reduce recurrence risk in post-surgical pancreatic cancer patients.
- Previous Phase 1 results showed that half of patients treated with Autogene Cevumeran developed strong T-cell immune responses and experienced significantly reduced relapse risk.
- The trial addresses the urgent need for new treatments in pancreatic cancer, where only one in three to four patients survives five years despite surgery and chemotherapy.last year