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NOT YET RECRUITING
NCT04901741
PHASE2

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

Sponsor: TME Pharma AG

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-01

Completion Date

2029-03

Last Updated

2025-06-27

Healthy Volunteers

No

Interventions

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