A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.

Study Identifier:
KISIMA-02
CT.gov Identifier:
NCT05846516
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2022-501854-12-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

To Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
    • ECOG performance status of 0 or 1.
    • Patients with advanced or metastatic disease who completed at least 16 weeks of standard of care systemic chem-/chemoradiotherapy and achieved a partial response or stable disease.
    • Patients who underwent confirmed R0 or R1 resection and completed at least 3 months of combined peri-adjuvant multiagent chemotherapy.
    • No evidence of disease progression or recurrence.
    • Start of study treatment within 12 weeks from the last curative treatment (resected PDAC).
    • Patient must have completed 8-12 cycles of FOLFIRINOX or mFOLFIRINOX either as adjuvant, neoadjuvant, or perioperative (Part C)
    • Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
    • Archival tumor tissue availability for central KRAS analysis and research.
    Exclusion criteria
    • Not yet recovered from surgery (resected PDAC).
    • Gastro-intestinal bowel obstruction.
    • Other malignancy within the last 3 years.
    • Prior chemotherapy or targeted small molecule therapy within 14 (locally advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
    • Prior radiotherapy within 14 days (advanced/metastatic PDAC). No prior radiotherapy. in resected PDAC
    • Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
    • Diagnosis of immunodeficiency, and/or history of allogeneic organ transplant
    • Chronic systemic treatment with steroids or other immunosuppressive medications.
    • Active autoimmune disease requiring systemic treatment within the last 2 years.
    • Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment
    • Major (according to the Investigator's judgment) surgery within 12 weeks from initiation of study treatment
    • Use of Tamoxifen within 1 month prior to start of study treatment

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Pancreas
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Pancreas