NCT06941857

NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer

A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	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).
DRUG	Irinotecan	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).
DRUG	Folinic 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).
DRUG	5-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).
DRUG	NC410	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).
DRUG	Nivolumab	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).
DRUG	Ipilimumab	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).

Timeline

• Start date: 2025-09-04
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2025-04-24
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study