RecruitingEarly Phase 1NCT05916261

Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer

Clinical Study of Personalized Tumor Vaccines mRNA-0217/S001 and Pabolizumab in Patients With Advanced Pancreatic Cancer


Sponsor

Ruijin Hospital

Enrollment

54 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine — made from your tumor's specific mutations — combined with the immunotherapy drug pembrolizumab (Keytruda) in people with advanced solid tumors including pancreatic cancer. **You may be eligible if...** - You are 18 or older - You have a locally advanced, recurrent, or metastatic solid tumor confirmed by biopsy - Your cancer has not responded to standard treatments - You have good performance status and adequate organ function - You are willing to provide tumor tissue samples for vaccine creation **You may NOT be eligible if...** - You have active brain metastases (unless stable) - You have active autoimmune disease requiring medication - You are pregnant or breastfeeding - You have had severe prior reactions to immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPersonalized 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


Locations(1)

Ruijin-Hainan Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Qionghai, Hainan, China

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NCT05916261


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