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Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

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Trial Profile

Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 May 2023

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At a glance

  • Drugs Nivolumab (Primary) ; Sotigalimab (Primary) ; Gemcitabine; Paclitaxel
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PRINCE
  • Most Recent Events

    • 21 Jan 2023 Results assessing the impact of GCSF administration on OS, PFS, and time on treatment in the setting of mPDAC for a trial in which pts were administered chemo-IO combinations and a synthetic control arm using retrospective real-world data from patients who received standard-of-care chemo (PASCAL), presented at the 2023 Gastrointestinal Cancers Symposium.
    • 22 Sep 2022 Status changed from active, no longer recruiting to completed.
    • 07 Jun 2022 Primary endpoint has not been met. (1-year OS rate in the sotiga/chemo), as per Results presented at the 58th Annual Meeting of the American Society of Clinical Oncology
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