The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.
Patient with confirmed microsatellite-stable tumor pathology, if data available
Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who
Arm 1: stopped first-line treatment with gemcitabine/nab-paclitaxel after documented objective radiographic progression OR
Arm 2: stopped first-line treatment with FOLFIRINOX or modified FOLFIRINOX after documented objective radiographic progression
Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.
Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention
Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
TME Pharma AG
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator