Clinical trialPhase 1 / Phase 2Completed
Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
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
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 21 July 2017
- Expected end
- 25 February 2022
- Enrollment
- 129 participants
- Sites
- 7
- Primary outcomes
- Phase 1b Primary Safety Outcome; 1-year Overall Survival Rate
- Sponsor
- Other
- Results posted
- 2022-08-11
- Last update
- 23 December 2022
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Papers 5
- Builds on itSotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic ana… DOI 10.1038/s41591-022-01829-9↗
- Builds on itCD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment… DOI 10.1016/s1470-2045(20)30532-5↗
- BackgroundPrevailing over T cell exhaustion: New developments in the immunotherapy of pancreatic cancer. DOI 10.1016/j.canlet.2016.02.057↗
- BackgroundProjecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the Un… DOI 10.1158/0008-5472.can-14-0155↗
- BackgroundIncreased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. DOI 10.1056/nejmoa1304369↗