Clinical Trial

OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC

Study acronym: TEDOPAM
Active, Not Recruiting Phase 2
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Summary
TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-01-15; most recent amendment 2025-07-22.
Status change: Recruiting → Active, Not Recruiting 2025-07-22
Status change: Not Yet Recruiting → Recruiting 2019-02-26
Trial Details
NCT Number NCT03806309
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: OSE Immunotherapeutics
Conditions Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer
Enrollment 106 participants
Start Date 2021-04-10
Primary Completion 2024-12-09 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-25