Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
- Trial number:
- NCT04390763
- Trial phase:
- 2
- Study type:
- Immunotherapy, Chemotherapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Signed informed consent must be obtained prior to participation in the study.Male or female ≥ 18 years of age at the time of informed consent. Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1. Participants must have a site of disease amenable to biopsy, and be candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a tumor biopsy at screening and during therapy on the study. In the event a new biopsy cannot be safely performed at study entry, an archival sample (collected <6 months prior) may be substituted following documented discussion with Novartis. ECOG performance status ≤ 1.