NCT04901741

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

An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TME Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Olaptesed pegol	400 mg per week as continous infusion until progression or intolerable toxicity
DRUG	Pembrolizumab	200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-03-01
• Completion: 2029-03-01
• First posted: 2021-05-25
• Last updated: 2025-06-27

Regulatory

• FDA-regulated drug study