Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis

Study Identifier
M20-732
CT.gov Identifier
NCT04807972
EudraCT Identifier
2020-005767-31
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Pancreatic Cancer
    • Study Drug
  • ABBV-927
  • Budiglimab
  • modified FOLFIRINOX
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body weight \>= 35 kg. * Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease. * Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1). * Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.
    Exclusion Criteria:
    * Participants with locally advanced disease. * Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma. * Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma. * Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months. * Prior radiotherapy to any measurable metastatic lesion at any time. * Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion). * Known metastases to the central nervous system (CNS).

    Protocol Summary

    Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.

    ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.

    Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    UCHSC Anschultz Cancer Pavilion /ID# 227841
    Aurora, Colorado, United States, 80045-2517
    Status
    Not applicable
    Location
    Johns Hopkins Hospital /ID# 226713
    Baltimore, Maryland, United States, 21287
    Status
    Not applicable
    Location
    Univ Hosp Cleveland /ID# 226807
    Cleveland, Ohio, United States, 44106
    Status
    Not applicable
    Location
    Cleveland Clinic Main Campus /ID# 231135
    Cleveland, Ohio, United States, 44195
    Status
    Not applicable
    Location
    Penn State Hershey Medical Ctr /ID# 229837
    Hershey, Pennsylvania, United States, 17033-2360
    Status
    Not applicable
    Location
    Monash Medical Centre /ID# 231379
    Clayton, Victoria, Australia, 3168
    Status
    Not applicable
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