Actively Recruiting
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-05-05
20
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
NextCure, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
CONDITIONS
Official Title
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Metastatic pancreatic ductal adenocarcinoma confirmed by tissue testing
- Presence of metastatic disease
- No prior systemic treatment for pancreatic cancer
- Measurable disease according to RECIST 1.1 criteria
- Adequate organ and bone marrow function based on study tests
- Negative serum pregnancy test for women of childbearing potential
- Use of acceptable birth control for both women and men during the study
- Ability to understand the study, its risks, and to provide informed consent
You will not qualify if you...
- Prior chemotherapy for pancreatic cancer or chemotherapy within 5 years for other cancers
- Previous radiotherapy for pancreatic cancer
- Use of any investigational drug or device within 28 days before treatment start
- Major surgery within 28 days before treatment, except diagnostic procedures
- Need for other cancer therapies during the study
- Prior treatment with specific immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, anti-Lag-3)
- Live or live-attenuated vaccine within 28 days before starting study drug
- History of tissue or organ transplant
- Uncontrolled acute or chronic medical illness
- Central nervous system metastases or carcinomatous meningitis
- Active progressing cancer besides pancreatic cancer
- Active autoimmune disease
- Diagnosis of immunodeficiency or chronic steroid use exceeding 10 mg prednisone daily
- Conditions that might interfere with study participation or results as judged by investigators
- Requirement for daily supplemental oxygen
- History of lung diseases such as interstitial lung disease, pneumonitis, COPD, asthma requiring medication
- Known HIV infection
- Active or chronic hepatitis B or C
- Unable to tolerate venous access procedures
- Psychiatric or substance use disorders interfering with study compliance
- Pregnant or breastfeeding women
- Positive urine pregnancy test within 72 hours before study drug start for women of childbearing potential
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
C
Colleen Apostol, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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