Clinical trialPhase 1Terminated
Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen DNA Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
- Outcome
- Stopped earlyLoss of funding (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 5 January 2018
- Expected end
- 13 August 2022
- Enrollment
- 15 participants
- Sites
- 2
- Primary outcomes
- Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
- Sponsor
- Other
- Results posted
- 2022-10-04
- Last update
- 10 October 2023
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Brief summary public domain (ClinicalTrials.gov)
This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen DNA vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen DNA vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be administered with an electroporation device. The hypothesis of this study is that neoantigen DNA vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.
Detailed description public domain (ClinicalTrials.gov)
-Subjects will be enrolled within 12 weeks of surgery and standard of care adjuvant chemotherapy will last approximately 12 weeks with an additional 12 weeks of standard of care adjuvant chemotherapy or adjuvant chemoradiation. The first vaccine may be administered following confirmation of disease-free status and within 60 days following date of repeat imaging. From time of enrollment to first vaccine could be up to 45 weeks.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event [Through week 24]. Count Of Participants, Participants. Abdominal pain: Personalized Neoantigen DNA Vaccine (n=11): 1. Bruising: Personalized Neoantigen DNA Vaccine (n=11): 1. Chills: Personalized Neoantigen DNA Vaccine (n=11): 1. Conjunctivitis: Personalized Neoantigen DNA Vaccine (n=11): 1. Fatigue: Personalized Neoantigen DNA Vaccine (n=11): 2. Fever: Personalized Neoantigen DNA Vaccine (n=11): 1. Injection site pain: Personalized Neoantigen DNA Vaccine (n=11): 10. Injection site reaction: Personalized Neoantigen DNA Vaccine (n=11): 2. Hypertension: Personalized Neoantigen DNA Vaccine (n=11): 1. Muscle soreness: Personalized Neoantigen DNA Vaccine (n=11): 1. Myalgia: Personalized Neoantigen DNA Vaccine (n=11): 10. Nausea: Personalized Neoantigen DNA Vaccine (n=11): 1. Pain: Personalized Neoantigen DNA Vaccine (n=11): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Immunogenicity of the Neoantigen DNA Vaccine as Measured by ELISPOT Analysis [Through week 77]. Count Of Participants, Participants. Personalized Neoantigen DNA Vaccine (n=9): 9.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Immunogenicity of the Neoantigen DNA Vaccine as Measured by Multiparametric Flow Cytometry [Through week 77].