NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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

Eligibility criteria

Qualifiers

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.

Metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma.

Have metastatic disease

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Oxaliplatin
  • Irinotecan
  • Folinic Acid
  • 5-Fluorouracil (5-FU)
  • NC410
  • Nivolumab
  • Ipilimumab

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

NextCure, Inc.

Collaborator

Lustgarten Foundation

Collaborator