A randomized double-blind phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) | NYU Langone Health

Go Back to All Clinical Trials

A randomized double-blind phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Metastatic Pancreatic Ductal Adenocarcinoma
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery. 2) Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1. 3) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 4) Adequate organ function (assessed by central laboratory for eligibility).

You may not be eligible for this study if the following are true:

1) Previous systemic anti-cancer treatment for metastatic PDAC. 2) Pancreatic neuroendocrine, acinar, or islet tumors. 3) Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening). 4) Impaired cardiac function or clinically significant cardio-vascular disease.