NCT06941857 NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
| NCT ID | NCT06941857 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-09-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
Eligibility Criteria
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.
Contact & Investigator
Katherine Bever, MD
PRINCIPAL INVESTIGATOR
SKCCC Johns Hopkins Medical Institution
Frequently Asked Questions
Who can join the NCT06941857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06941857 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06941857 currently recruiting?
Yes, NCT06941857 is actively recruiting participants. Contact the research team at GIClinicalTrials@jhmi.edu for enrollment information.
Where is the NCT06941857 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06941857 clinical trial?
NCT06941857 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Katherine Bever, MD at SKCCC Johns Hopkins Medical Institution. The trial plans to enroll 20 participants.
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