Phase 3 study for Metastatic Pancreatic Cancer

A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Quintiliani, Jennifer; Jarquin-Castillo, Katherine

    Trial Phone: 321.843.2026 ; 321.841.1077

  • IRB No: WIRB 20162918

    Protocol Abbrev: TRIO_ARMO_AM0010-301

    Principal Investigator: Sreeram Maddipatla, MD

    Sub Investigators: Thomas, Sajeve MD; Kayaleh, Omar MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: AM0010-301

    Treatment: Chemotherapy

    Applicable Disease Sites: Pancreatic Cancer

    Therapies Involved: Biological: AM0010, Drug: Folfox ID: NCT02923921

  • Objective

    To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer

  • Key Eligibility

    Inclusion Criteria:
    1.The presence of metastatic pancreatic adenocarcinoma
    2.Measurable disease per RECIST v.1.1
    3.Patient must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
    4.Eastern Cooperative Oncology Group Performance Status of 0 - 1
    5.Patient must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
    6.Patients must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
    7.Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
    8.No peripheral neuropathy
    9.No known history of dihydropyrimidine dehydrogenase deficiency

    Exclusion Criteria:
    1.Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
    2.Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
    3.Patient has received prior treatment with AM0010 or fluoropyrimidine/platinum containing regimen
    4.Patients who were intolerant of a gemcitabine containing regimen.
    5.History of positivity for human immunodeficiency virus
    6.Chronic active or active viral hepatitis A, B, or C infection
    7.Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
    8.Pregnant or lactating women
    9.Patients with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
    10.Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
    11.Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
    12.Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1