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

Johns Hopkins Medicine

Status and phase: Begins enrollment this month; Phase 2

Conditions: Pancreatic Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06941857

J2541

IRB00486324 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arm 1 - FOLFIRINOX/NC410/Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: Irinotecan

Drug: NC410

Drug: Folinic Acid

Drug: Oxaliplatin

Drug: 5-Fluorouracil (5-FU)

Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

Drug: Irinotecan

Drug: NC410

Drug: Folinic Acid

Drug: Oxaliplatin

Drug: 5-Fluorouracil (5-FU)