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Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer

NCT05916261 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-10-26

No results posted yet for this study

Summary

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

  • Advanced Pancreatic Cancer

Interventions

BIOLOGICAL

Personalized neoantigen tumor vaccine

neoantigen 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

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Baiyong Shen, M.D.&Ph.D · Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916261 on ClinicalTrials.gov