Actively Recruiting
Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer
Led by Ruijin Hospital · Updated on 2023-10-26
54
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of Advanced Pancreatic Cancer. The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.
CONDITIONS
Official Title
Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 18 years of age or older at time of consent
- Locally advanced, recurrent, or metastatic solid tumors confirmed by biopsy or histology within past 6 months
- Failure of standard treatment or not suitable for standard treatment
- No copy number variations or loss of heterozygosity in HLA-related genes by gene sequencing
- Advanced or metastatic lesions confirmed by immunohistochemistry with sufficient tissue for sequencing
- Life expectancy of at least 4 months
- Measurable disease per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and bone marrow function with no recent use of certain growth factors or transfusions
- Fertile patients must agree to reliable contraception during trial and 90 days after last dose; negative pregnancy test for females of childbearing potential
- Negative virological tests for CMV, EBV, HIV, HBV, HCV, and syphilis at baseline
You will not qualify if you...
- Chemotherapy, hormone therapy, traditional Chinese medicine, or biological cancer treatment within 4 weeks prior to first dose (6 weeks for mitomycin and nitrosoureas)
- Major surgery within 4 weeks before first dose or planned major surgery during study
- History of allogeneic stem cell or organ transplantation or planned organ transplantation
- Prior tumor vaccines or cell therapy
- Uncontrolled brain metastases, spinal cord compression, or cancerous meningitis
- Other progressing malignant tumors requiring active treatment in past 2 years (except certain cured cancers)
- History of interstitial lung disease or pulmonary fibrosis
- Serious cardiovascular or cerebrovascular diseases including arrhythmias, heart failure, acute coronary syndrome, or stroke within 6 months
- Serious or uncontrollable diseases such as severe allergies, immunodeficiency, uncontrolled infections, active ulcers, or severe liver/kidney disease
- Participation in other clinical trials within 4 weeks prior to first dose
- Current systemic steroid use (except inhaled steroids)
- Pregnant or lactating women
- Tumor invasion of large blood vessels with bleeding risk
- Significant thyroid dysfunction
- Active pneumonia or uncontrolled pleural, pericardial effusion, or ascites
- Unresolved adverse reactions from previous anti-tumor therapy above grade 1 except hair loss
- Positive for HBsAg with high HBV DNA or positive HCV Ab with high HCV RNA
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin-Hainan Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Qionghai, Hainan, China
Actively Recruiting
Research Team
X
Xinjing Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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