A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer
Summary
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
Arms & interventions
- DrugOxaliplatin
65mg/m2 will be administered as a 120 minute IV Infusion (-10/+ 20 minutes) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
- DrugIrinotecan
150 mg/m2 will be administered as a 90 minute IV Infusion (-10/+ 20 minutes) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
- DrugFolinic Acid
50 mg will be administered as a 15 minute IV infusion (-5/+20 min) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. Folinic acid can be given concurrent with irinotecan. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
- Drug5-Fluorouracil (5-FU)
2400 mgm2 will be administered as a continuous IV Infusion (-120/+ 120 minutes) over approximately 46 hours on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
- DrugNC410
100 mg will be administered as a 60 minute IV Infusion (-10/+ 20 minutes) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
- DrugNivolumab
400 mg will be administered as a 30 minute IV Infusion (-5/+20 minutes) once on Cycle 1 Day 1. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
- DrugIpilimumab
50 mg will be administered as a 30 minute IV Infusion (-5/+20 minutes) once on Cycle 1 Day 1. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
Outcome measures
Primary
Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
When calculating the incidence of Adverse Events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
Time frame: 4 years
Secondary
Progression- Free Survival (PFS)
Time frame: 4 years
Response Rate (ORR)
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Eligibility criteria
Study locations (1)
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231