metastatic pancreatic ductal adenocarcinoma (mPDAC)

Novartis

III

First

NIS793 + gemcitabine/nab-paclitaxel vs placebo + gemcitabine/nab-paclitaxel

HUG

To confirm the recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel (Safety run-in part)
To compare OS in participants with mPDAC treated as the first line treatment with the combination of NIS793, gemcitabine and nab-paclitaxel to the combination of placebo with gemcitabine and nab-paclitaxe (Randomized part)

• Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery
• Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Adequate organ function (assessed by central laboratory for eligibility)
• Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.

• Previous systemic anti-cancer treatment for metastatic PDAC
• Pancreatic neuroendocrine, acinar, or islet tumors
• 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).
• Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.
• Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed > 2 weeks prior to start of study treatment).
• Impaired cardiac function or clinically significant cardio-vascular disease
• Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.
• Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
• Serious non-healing wounds.
• Pregnant or breast-feeding women
• Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
• Virginie.Ancrenaz@hcuge.ch&Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)