NCT06941857 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
What this study is about
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
View original scientific description
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
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).
Primary outcome measures
Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
Time frame: 4 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Baltimore, Maryland
Collaborators
NextCure, Inc., Lustgarten Foundation
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations