Clinical trialPhase 1Terminated
Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
- Outcome
- Stopped earlyInsufficient funding/staff (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 13 February 2020
- Expected end
- 6 July 2023
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events
- Sponsor
- Other
- Results posted
- 2023-05-31
- Last update
- 17 July 2024
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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 peptide vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen peptide vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be co-administered with poly-ICLC. The hypothesis of this study is that neoantigen peptide vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events [Through 30 days following completion of treatment (median follow-up of 107 days, full range of 88-157 days)]. Number, participants. Grade 3 ascites: Neoantigen Peptide Vaccine (n=10): 1. Grade 3 anemia: Neoantigen Peptide Vaccine (n=10): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Immune Response as Measured by ELISPOT Analysis [Baseline through week 52]. Count Of Participants, Participants. Neoantigen Peptide Vaccine (n=9): 9.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD4) [Baseline through week 52]. Count Of Participants, Participants. Neoantigen Peptide Vaccine (n=9): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD8) [Baseline through week 52]. Count Of Participants, Participants. Neoantigen Peptide Vaccine (n=9): 7.