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

Study acronym: TEDOPAM
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 30, 2023 to Dec 9, 2024v6 Show 5 more changesShow less
    • Start date: Jul 31, 2019 to Apr 10, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 30, 2024 to Dec 2025
    • Site details revised at 28 of 28 sites
    • Study title shortened, about 6 words
  2. Primary completion date: Dec 30, 2022 to Dec 30, 2023
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    v5
  3. Enrollment target: 156 to 106v4 Show 6 more changesShow less
    • Start date: Feb 7, 2019 to Jul 31, 2019
    • Interventions: FOLFIRI (Drug), Nivolumab (Drug), OSE2101 (Drug) to FOLFIRI (Drug), OSE2101 (Drug)
    • Eligibility criteria shortened, about 206 words
    • Collaborators: 2 to 1
    • Study title shortened, about 9 words
    • Study arms: 3 to 2
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2019 to Feb 7, 2019
    • Site details revised at 28 of 28 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03806309
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: OSE Immunotherapeutics
Conditions
(from sponsor)		 Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer
Related terms Neoplasm Metastasis
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov