RECRUITING

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

Conditions

Pancreatic Cancer 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 Ductal Adenocarcinoma (PDAC)Carcinoma Pancreas

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer

Quick Facts

Study Start:2025-07

Study Completion:2030-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06941857

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Colleen Apostol, RN

CONTACT

410-614-3644

GIClinicalTrials@jhmi.edu

Joann Santmyer, RN

CONTACT

410-614-3644

GIClinicalTrials@jhmi.edu

Principal Investigator

Katherine Bever, MD

PRINCIPAL_INVESTIGATOR

SKCCC Johns Hopkins Medical Institution

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Katherine Bever, MD, PRINCIPAL_INVESTIGATOR, SKCCC 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

Study Start Date2025-07

Study Completion Date2030-07

Study Record Updates

Study Start Date2025-07

Study Completion Date2030-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Pancreatic Cancer