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

Summary

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

Conditions

• Pancreatic Cancer

Interventions

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).

Sponsors & Collaborators

• NextCure, Inc.

  collaborator INDUSTRY

• Lustgarten Foundation

  collaborator OTHER

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Katherine Bever, MD · SKCCC Johns Hopkins Medical Institution

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-04

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations