Pancreatic CancerPhase 2NCT06941857
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
A Phase 2 study testing Oxaliplatin, Irinotecan and Folinic Acid in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Oxaliplatin, Irinotecan and Folinic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Colleen Apostol, RN, 410-614-3644, GIClinicalTrials@jhmi.edu
Katherine Bever, MD
About this study
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
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
- Conditions
- Pancreatic Cancer
- Being tested
- Oxaliplatin, Irinotecan, Folinic Acid, 5-Fluorouracil (5-FU), NC410
- 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
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
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).
IrinotecanDrug
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 AcidDrug
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)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).
NC410Drug
Also called NextCure LAIR-2 fusion protein
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).
NivolumabDrug
Also called OPDIVO
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).
IpilimumabDrug
Also called YERVOY
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - FOLFIRINOX/NC410/Nivolumab | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Folinic Acid; Drug: 5-Fluorouracil (5-FU); Drug: NC410; Drug: Nivolumab |
| Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Folinic Acid; Drug: 5-Fluorouracil (5-FU); Drug: NC410; Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (4)
Progression- Free Survival (PFS)
PFS is defined as the number of months from the date of first dose to disease progression (PD as assessed using RECIST 1.1 criteria) or death due to any cause. PFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis. PFS will be censored at time of first dose for patients that do not have a follow-up scan. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30percent decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20percent increase in sum of diameters of target lesions, Stable Disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 4 years
Response Rate (ORR)
ORR is defined as the number of subjects with PR or CR according to RECIST 1.1. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. CR = disappearance of all target lesions, PR is =>30percent decrease in sum of diameters of target lesions, progressive disease (PD) is >20percent increase in sum of diameters of target lesions, stable disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions.
Measured: 4 years
Disease Control Rate (DCR)
DCR is defined as the number of subjects achieving stable disease or better (SD, PR or CR) according to RECIST 1.1. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30percent decrease in sum of diameters of target lesion, Stable Disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions.
Measured: 4 years
Overall Survival (OS)
OS is defined as the number of months from the date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start4 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- NextCure, Inc., Lustgarten Foundation
- Responsible party
- Sponsor
- Investigators
- Katherine Bever, MD, Principal investigator, SKCCC Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941857
- Sponsor's protocol ID
- J2541
- Other IDs
- IRB00486324
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06941857
- Acronym / sponsor ID
- J2541
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- NextCure, Inc., Lustgarten Foundation
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaliplatin65mg/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). | Drug | Arm 1 - FOLFIRINOX/NC410/Nivolumab, Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
| Irinotecan150 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). | Drug | Arm 1 - FOLFIRINOX/NC410/Nivolumab, Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
| Folinic Acid50 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). | Drug | Arm 1 - FOLFIRINOX/NC410/Nivolumab, Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
| 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). | Drug | Arm 1 - FOLFIRINOX/NC410/Nivolumab, Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
| NC410Also: NextCure LAIR-2 fusion protein100 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). | Drug | Arm 1 - FOLFIRINOX/NC410/Nivolumab, Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
| NivolumabAlso: OPDIVO400 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). | Drug | Arm 1 - FOLFIRINOX/NC410/Nivolumab, Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
| IpilimumabAlso: YERVOY50 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). | Drug | Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab |
Primary outcome
Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
Time frame: 4 years
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 secondary outcomes
Progression- Free Survival (PFS)
Time frame: 4 years
Response Rate (ORR)
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Bever, MD principal investigator
SKCCC Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Irinotecan and Folinic Acid in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colleen Apostol, RN (410-614-3644, GIClinicalTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.