NCT04161755
进行中（未招募）
1 期
Phase 1 Clinical Trial of Personalized Neoantigen Tumor Vaccines and Programmed Death-Ligand 1 (PD-L1) Blockade in Patients With Surgically Resected Pancreatic Cancer
概览
- 阶段
- 1 期
- 干预措施
- Atezolizumab
- 疾病 / 适应症
- Pancreatic Cancer
- 发起方
- Memorial Sloan Kettering Cancer Center
- 入组人数
- 29
- 试验地点
- 12
- 主要终点
- Drug related toxicity
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The purpose of this study is to evaluate the safety or treating pancreatic cancer with surgery to remove cancerour tissue, followed by atezolizumab, followed by a personalized cancer vaccine (PCV), and then with chemotherapy.
研究者
入排标准
入选标准
- •Subjects must be \>/= 18 years of age at time of informed consent
- •Able to comply with the study protocol, in the investigator's judgment
- •Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection
- •Tumors must be radiographically resectable, defined as:
- •A clear fat plane around the celiac and superior mesenteric arteries
- •patent superior mesenteric and portal veins without primary tumor involvement
- •No encasement of the superior mesenteric vein or portal veins
- •No encasement of the superior mesenteric or hepatic arteries
- •No metastatic disease
- •No extra-regional nodal disease
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Prior neoadjuvant treatment or radiation therapy for PDAC
- •Prior therapy with uPD-1 antibody or any other immune therapy
- •Borderline resectable, locally unresectable or metastatic PDAC
- •Pancreas tumor histology other than PDAC
- •Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment
- •Life expectancy less than 12 weeks
- •Inability to comply with study and/or follow-up procedures
- •Any other malignancy for which the patient is undergoing active treatment which will be concurrent with the investigational agent in this study.
- •Patients with unresolved Clavien-Dindo \>/= Grade 3 (Section 20.0 APPENDICES ,Appendix 2) postoperative complications
研究组 & 干预措施
Pancreatic Cancer
Radiologically resectable primary pancreatic tumors
干预措施: Atezolizumab
Pancreatic Cancer
Radiologically resectable primary pancreatic tumors
干预措施: RO7198457
Pancreatic Cancer
Radiologically resectable primary pancreatic tumors
干预措施: mFOLFIRINOX
结局指标
主要结局
Drug related toxicity
时间窗: 2 years
The primary objective of this trial is to evaluate the safety of a personalized tumor vaccine combined with atezolizumab and mFOLFIRINOX
研究点 (12)
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相关资讯
NCT/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.mRNA Cancer Vaccines: Recent Advances and Future Directions in Immunotherapy- mRNA vaccines have emerged as a promising platform for cancer immunotherapy due to their cost-effectiveness, safety, and rapid development potential.
- Neoantigen identification is crucial for developing effective mRNA cancer vaccines, with recent studies focusing on proteogenomic approaches and tumor-associated antigens.
- Adjuvants like CpG oligodeoxynucleotides and monophosphoryl lipid A can enhance mRNA vaccine efficacy by stimulating the immune system.
- Clinical trials are exploring the potential of personalized mRNA vaccines to activate neoantigen-specific T cells and improve outcomes in various cancers.