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
Price :
$35
*
At a glance
- Drugs Nivolumab (Primary) ; Sotigalimab (Primary) ; Gemcitabine; Paclitaxel
- Indications Adenocarcinoma; Pancreatic cancer
- Focus Adverse reactions; Therapeutic Use
- Acronyms PRINCE
- 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