Study on Immunotherapy Before and After Surgery for Patients with Resectable Pancreatic Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02451982

Provider View

This clinical trial is exploring different combinations of immunotherapy treatments given before and after surgery to see if they can improve outcomes for patients with pancreatic cancer that can be surgically removed.

Patient Parameters

Program Overview

This study is testing new immunotherapy treatments for pancreatic cancer, which is a challenging disease to treat with traditional chemotherapy. Researchers are investigating how these treatments can help the immune system recognize and attack cancer cells. They are using a special cancer vaccine called GVAX, combined with a chemotherapy drug, cyclophosphamide, to boost the immune response before and after surgery. The study also looks at how blocking certain signals, like PD-1, can enhance the immune system's ability to fight cancer. By examining immune cells from patients, researchers aim to understand how these treatments affect the immune system and improve patient outcomes.

Description

This clinical trial is focused on finding new ways to treat pancreatic cancer using immunotherapy, which helps the body's immune system fight cancer. Pancreatic cancer is tough to treat because it often resists chemotherapy and can hide from the immune system. Researchers are testing a vaccine called GVAX, which is designed to activate the immune system against pancreatic cancer. They are combining this vaccine with a chemotherapy drug, cyclophosphamide, to enhance the immune response both before and after surgery.

The study has shown that the vaccine can help immune cells enter the tumor, forming structures similar to lymph nodes, which are important for fighting infections. However, the vaccine also increases signals that can suppress the immune system, such as PD-1. This study will test if blocking PD-1 can improve the immune response when used with the vaccine.

Researchers will collect and analyze immune cells from patients to understand how these treatments work at the genetic and protein levels. They will compare results from patients who live longer with those who do not, to see how effective and safe the treatments are. The goal is to improve the health and survival of patients with pancreatic cancer who undergo surgery.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed or suspected pancreatic cancer in the head, neck, or uncinate process of the pancreas.
  • Cancer must be removable by surgery.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Adequate organ function based on specific lab tests.
  • Must agree to use effective birth control methods.

Exclusion Criteria

  • Have received any previous cancer treatment or immunotherapy for pancreatic cancer.
  • Have a history of autoimmune diseases, except for Graves or Hashimoto's disease, vitiligo, and type I diabetes.
  • Use of systemic steroids within the last 14 days.
  • Have an active infection.
  • Are pregnant or breastfeeding.
  • Have another type of cancer or blood disorder, with some exceptions.
  • Have had severe allergic reactions to monoclonal antibodies or components of the study drugs.
  • Have a known history of HIV, hepatitis B, or hepatitis C infections.
  • Have low oxygen levels (less than 92%) on room air.
  • Are on home oxygen therapy.

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