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Study of NC410 and FOLFIRINOX with Nivolumab for Metastatic Pancreatic Cancer

This study is looking at a new combination of treatments for people with metastatic pancreatic cancer (cancer that has spread to other parts of the body) who haven't received prior treatment. It combines NC410 with FOLFIRINOX (a chemotherapy regimen including Oxaliplatin, Irinotecan, Folinic Acid, and 5-Fluorouracil) and Nivolumab, and in some cases, Ipilimumab. The main goal is to understand the safety of this treatment combination and identify any new side effects. You may be able to join if you are 18 or older, have metastatic pancreatic cancer, and have not yet received treatment for it. The study plans to enroll 20 participants.

Study design
This is an interventional study with 20 planned participants. The two treatment arms will enroll sequentially.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure unexpected toxicities for 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06941857

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~20 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:OxaliplatinIrinotecanFolinic Acid5-Fluorouracil (5-FU)NC410Nivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
Measured over 4 years

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT06941857

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Katherine Bever, MD · PRINCIPAL_INVESTIGATOR · SKCCC Johns Hopkins Medical Institution

Who to contact

Colleen Apostol, RN
[email protected]
410-614-3644
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.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.