drugset / Trial / NCT04901741

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

NCT04901741

Phase 2 Not yet recruiting 60 enrolled TME Pharma AG Merck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2026-01
Primary completion
2028-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaptesed pegol Oligonucleotide (other) 400 mg Other
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous