Study on NC410 and FOLFIRINOX with Nivolumab and Possibly Ipilimumab for Untreated Metastatic Pancreatic Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT06941857

Provider View

This clinical trial is testing a new combination of treatments for patients with metastatic pancreatic cancer who have not received prior treatment. The study aims to evaluate the safety of the treatment and identify any new side effects.

Patient Parameters

Program Overview

The purpose of this study is to test the safety of a new treatment combination for patients with metastatic pancreatic cancer who have not been treated before. The treatment includes NC410, FOLFIRINOX, and Nivolumab, with or without Ipilimumab. Researchers want to see if this combination is safe and to identify any new side effects that may occur.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status, able to carry out normal activities or light work.
  • Have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
  • Have not received any previous treatment for pancreatic cancer.
  • Have cancer that can be measured by standard criteria.
  • Have good organ and bone marrow function as shown by specific lab tests.
  • Women who can have children must have a negative pregnancy test.
  • Both men and women must agree to use effective birth control during the study.
  • Must understand the study, its requirements, risks, and be willing to sign a consent form.

Exclusion Criteria

  • Have had previous chemotherapy for pancreatic cancer or any chemotherapy within the last 5 years for other cancers.
  • Have received radiation therapy for pancreatic cancer.
  • Have used any experimental drugs or devices within 28 days before starting the study.
  • Have had major surgery within 28 days before starting the study, except for diagnostic surgery.
  • Are expected to need other cancer treatments during the study.
  • Have had previous treatments with certain immune therapies.
  • Have received a live vaccine within 28 days before starting the study.
  • Have had a tissue or organ transplant.
  • Have uncontrolled medical conditions.
  • Have cancer that has spread to the brain or spinal cord.
  • Have another active cancer that needs treatment.
  • Have an active autoimmune disease.
  • Have an immune deficiency or are on high-dose steroids.
  • Have any condition that could interfere with the study or is not in the best interest of the patient to participate.
  • Need daily oxygen support.
  • Have certain lung diseases.
  • Have HIV, hepatitis B, or hepatitis C.
  • Cannot tolerate blood draws or venous access.
  • Have a psychiatric or substance use disorder that would interfere with the study.
  • Are pregnant or breastfeeding.
  • Women who can have children and have a positive pregnancy test before starting the study.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Comprehensive Cancer Center21231BaltimoreMaryland

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