NC410 And FOLFIRINOX In Combination With Nivolumab With Or Without Ipilimumab In Patients With Untreated Metastatic Pancreatic Cancer

Study Overview

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

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

N/A

Pancreatic Cancer

DRUG: Oxaliplatin
DRUG: Irinotecan
DRUG: Folinic Acid
DRUG: 5-Fluorouracil (5-FU)
DRUG: NC410
DRUG: Nivolumab
DRUG: Ipilimumab

J2541
IRB00486324 (OTHER Identifier) (OTHER: Johns Hopkins Medical Institution)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-04
First Submitted that Met QC Criteria 2025-04-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-08
First Posted (ESTIMATED) 2025-04-24	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1 - FOLFIRINOX/NC410/Nivolumab	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 followe 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).
EXPERIMENTAL: Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab	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 followe 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1 - FOLFIRINOX/NC410/Nivolumab

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 followe

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).

EXPERIMENTAL: Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

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 followe

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).

Primary Outcome Measures	Measure Description	Time Frame
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.	4 years

Secondary Outcome Measures	Measure Description	Time Frame
Progression- Free Survival (PFS)	PFS is defined as the number of months from the date of first dose to disease progression (PD as assessed using RECIST 1.1 criteria) or death due to any cause. PFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis. PFS will be censored at time of first dose for patients that do not have a follow-up scan. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30percent decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20percent increase in sum of diameters of target lesions, Stable Disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.	4 years
Response Rate (ORR)	ORR is defined as the number of subjects with PR or CR according to RECIST 1.1. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. CR = disappearance of all target lesions, PR is =>30percent decrease in sum of diameters of target lesions, progressive disease (PD) is >20percent increase in sum of diameters of target lesions, stable disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions.	4 years
Disease Control Rate (DCR)	DCR is defined as the number of subjects achieving stable disease or better (SD, PR or CR) according to RECIST 1.1. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30percent decrease in sum of diameters of target lesion, Stable Disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions.	4 years
Overall Survival (OS)	OS is defined as the number of months from the date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.	4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Colleen Apostol, RN

Phone Number: 410-614-3644

Email: GIClinicalTrials@jhmi.edu

Study Contact Backup

Name: Joann Santmyer, RN

Phone Number: 410-614-3644

Email: GIClinicalTrials@jhmi.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
Have metastatic disease
Must not have received prior systemic treatment for pancreatic cancer.
Have measurable disease based on RECIST 1.1.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
For both Women and Men, must use acceptable form of birth control while on study.
Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines.

Have had prior chemotherapy for pancreatic cancer or prior chemotherapy within 5 years of enrollment for other cancer diagnoses.
Has received radiotherapy for pancreatic cancer.
Are receiving or have received any investigational agent or used an investigational device within 28 days prior to Day 1 of treatment in this study.
Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study.
Is expected to require any other form of systemic or localized antineoplastic therapy while on study.
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies.
Has received a live vaccine or live-attenuated vaccine within 28 days prior to the first dose of study drug.
Prior tissue or organ allograft regardless of need for immunosuppression, including corneal allograft.
Has uncontrolled acute or chronic medical illness.
Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has known additional malignancy that is progressing and requires active treatment.
Has active autoimmune disease.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Requirement for daily supplemental oxygen.
History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
Known history of human immunodeficiency virus (HIV).
Active or chronic hepatitis B or hepatitis C.
Unable to undergo venipuncture and/or tolerate venous access.
Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.
Pregnant or breastfeeding
A WOCBP who has a positive urine pregnancy test within 72 hours prior to study drug initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

NextCure, Inc.
Lustgarten Foundation

Investigators

PRINCIPAL_INVESTIGATOR: Katherine Bever, MD, SKCCC Johns Hopkins Medical Institution

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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