Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer
ConditionAdvanced Pancreatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment
Subjects must be >/= 18 years of age at time of informed consent, regardless of gender
Subjects with locally advanced, recurrent or metastatic solid tumors confirmed by histology or cytology within the past 6 months, who have failed standard treatment or are currently not suitable for standard treatment
No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing
Disqualifiers
Has had chemotherapy, hormone therapy, traditional Chinese medicine, or biological cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug in this study)， prior to the first dose of study therapytherapy within 4 weeks ,Or within 5 half-lives of immunotherapy, molecular targeted therapy
Subjects have undergone major surgical procedures other than the diagnosis or biopsy of the current tumor within 4 weeks before the first dose of mRNA-0217/S001, or are expected to undergo major surgery during the study period
Subjects have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or those who plan to receive organ transplantation during this study
Subjects have previously received other tumor vaccines or cell therapy
Trial design
Design model
Single group
Treatments tested in this trial
Personalized neoantigen tumor vaccine
Biological/Vaccineneoantigen tumor vaccine with or without Pembrolizumab In dose escalation phase, subjects will receive neoantigen tumor vaccine only. In dose expansion phase, subjects will receive neoantigen tumor vaccine combination with Pembrolizumab
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: Personalized neoantigen vaccine or neoantigen tumor vaccine + PembrolizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) or Dose-limiting toxicity(DLT),If MTD is not reached, Biologically Effective Dose (BED)
The highest dose of a drug or treatment that does not cause unacceptable side effects.
Time frame
Up to 27 weeks2
Reaction of antigen-specific T cells in peripheral blood
mRNA-0217/S001 personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Time frame
Up to 27 weeks3
Objective response rate (ORR)
ORR calculates the ratio of the number of patients whose best response is complete remission (CR) or partial remission (PR) to the total number of evaluable patients according to RECIST 1.1 criteria. Those who have not been evaluated for lesion and tumor response will be regarded as non-evaluable patients and will not be counted.
Time frame
Up to 105 weeks4
Disease control rate (DCR)
DCR calculates the ratio of the number of patients whose best response is complete remission (CR), or partial remission (PR), or stable disease (SD) to the total number of evaluable patients according to RECIST 1.1 criteria. Those who have not been evaluated for lesion and tumor response will be regarded as non-evaluable patients and will not be counted.
Time frame
Up to 105 weeksSecondary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
During the trial conduction, all adverse events (including laboratory abnormality and clinical events) will be closely monitored, and all ≥ grade 3 adverse events per CTCAE (v 5.0) will be recorded, including but not limited to the toxicities potentially suspected to relate to injection procedures and/or mRNA Tumor Vaccine therapy as listed below: Local erythema at the injection site, local allergic reactions at the injection site, fatigue, fever, chills, flu-like manifestations, vomiting, centrocytopenia, other unexpected adverse events
Time frame
Up to 105 weeks2
Progression-free survival (PFS)
Progression-free Survival of Personalized mRNA Tumor Vaccine
Time frame
Up to 105 weeks3
overall survival (OS)
Overall Survival of Personalized mRNA Tumor Vaccine
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov