NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Un… (NCT06941857) | Clinical Trial Compass
RecruitingPhase 2
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
United States20 participantsStarted 2025-09-04
Plain-language summary
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
Who can participate
Age range18 Years
SexALL
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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 th…
What they're measuring
1
Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
Timeframe: 4 years
Trial details
NCT IDNCT06941857
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins