Recruiting

Phase 2

Observational StudyNC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06941857

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxaliplatin

Irinotecan

Folinic Acid

5-Fluorouracil (5-FU)

NC410

Study Details

Brief summary:

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

Conditions

Pancreatic Cancer

Study ID

NCT06941857

Start date

Sep 4, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - FOLFIRINOX/NC410/Nivolumab

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

Interventions

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).

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).

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).

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).

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).

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).

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 measure

Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation. [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Colleen Apostol, RN

410-614-3644 GIClinicalTrials@jhmi.edu

Locations

Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Colleen Apostol, RN

410-614-3644 GIClinicalTrials@jhmi.edu

Principal Investigator:

Katherine Bever, MD

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

Nivolumab
Ipilimumab
NC410 (NextCure LAIR-2 (Leukocyte-Associated Immunoglobulin-like Receptor-2) fusion protein)
Oxaliplatin
Irinotecan
Folinic Acid
5-Fluorouracil
Folfirinox
Immunotherapy
Anti-PD-1 (anti-check point inhibitor)
PD-L1 (check point inhibitor)
Anti-CTLA-4 (anti-cytotoxic T-lymphocyte-associated antigen 4)
Metastatic Pancreatic Cancer
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Carcinoma
Pancreas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-05-05.