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

NCT06941857 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: J2541IRB00486324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression- Free Survival (PFS)

  4 years

• Response Rate (ORR)

  4 years

• Disease Control Rate (DCR)

  4 years

• Overall Survival (OS)

  4 years

Study Arms (2)

Arm 1 - FOLFIRINOX/NC410/Nivolumab

EXPERIMENTAL

Drug: Oxaliplatin; Drug: Irinotecan; Drug: Folinic Acid; Drug: 5-Fluorouracil (5-FU); Drug: NC410; Drug: Nivolumab

Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

EXPERIMENTAL

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

Interventions

Oxaliplatin DRUG

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).

Arm 1 - FOLFIRINOX/NC410/Nivolumab; Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

Irinotecan DRUG

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).

Arm 1 - FOLFIRINOX/NC410/Nivolumab; Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

Folinic Acid DRUG

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).

Arm 1 - FOLFIRINOX/NC410/Nivolumab; Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

5-Fluorouracil (5-FU) DRUG

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).

Arm 1 - FOLFIRINOX/NC410/Nivolumab; Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

NC410 DRUG

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).

Also known as: NextCure LAIR-2 fusion protein

Arm 1 - FOLFIRINOX/NC410/Nivolumab; Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

Nivolumab DRUG

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).

Also known as: OPDIVO

Arm 1 - FOLFIRINOX/NC410/Nivolumab; Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

Ipilimumab DRUG

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).

Also known as: YERVOY

Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lustgarten Foundation: collaborator
• NextCure, Inc.: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Carcinoma

Interventions

Oxaliplatin; Irinotecan; Leucovorin; Fluorouracil; Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Katherine Bever, MD

  SKCCC Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Apostol, RN

CONTACT

410-614-3644; GIClinicalTrials@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)