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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Baltimore
Contact Information
Primary
Colleen Apostol, RN
GIClinicalTrials@jhmi.edu
410-614-3644
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2030-09
Participants
Target number of participants: 20
Treatments
Experimental: Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental: Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Related Therapeutic Areas
Sponsors
Collaborators: NextCure, Inc., Lustgarten Foundation
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov

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