RecruitingPhase 2NCT06941857

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

20 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called NC410 combined with the standard chemotherapy regimen FOLFIRINOX and the immunotherapy drug nivolumab (with or without ipilimumab) in patients with metastatic pancreatic cancer who have not yet received any treatment. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You have not received any prior treatment for your pancreatic cancer - Your disease is measurable on scans - Your performance status is good (ECOG 0–1) and organ function is adequate **You may NOT be eligible if...** - You have received prior chemotherapy for pancreatic cancer, or any chemotherapy within the past 5 years for other cancers - You have active autoimmune disease requiring treatment - You have had prior immunotherapy - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).