Trial of Nivolumab and BMS-813160 with or without GVAX for Locally Advanced Pancreatic Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03767582

This study is testing a combination of drugs, including nivolumab and BMS-813160, with or without GVAX, to see if they are safe and effective for patients with locally advanced pancreatic cancer who have already received chemotherapy and radiation.

Patient Parameters

Program Overview

The aim of this study is to find out if a combination of drugs, including nivolumab and BMS-813160, with or without GVAX, is safe for patients with locally advanced pancreatic cancer. Researchers want to see if this treatment can help the immune system better attack cancer cells in the pancreas.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of locally advanced pancreatic cancer that cannot be removed by surgery.
  • Agree to have a biopsy if needed for the study.
  • Agree to have imaging tests done if needed for the study.
  • Have not received any prior treatment for this type of cancer.
  • Be in good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 3 months.
  • Be able to swallow pills or capsules.
  • Have adequate organ function based on specific lab tests.
  • Be eligible to receive a specific type of chemotherapy called FOLFIRINOX.
  • Agree to receive radiation therapy at Johns Hopkins Hospital.
  • Agree to have a biopsy of the pancreatic cancer if not eligible for surgery.
  • Use effective birth control while participating in the study.
  • Understand and agree to sign a consent form.

Exclusion Criteria

  • Have received a different type of chemotherapy for pancreatic cancer.
  • Have received any cancer vaccines or biologics within 28 days before starting the study.
  • Have had previous treatment with certain immunotherapy drugs.
  • Have had an organ or tissue transplant.
  • Are currently in another cancer treatment study.
  • Are using immunosuppressive medications within 14 days before starting the study.
  • Have received any vaccine within 14 days before starting the study.
  • Are using growth factors within 14 days before starting the study.
  • Have a history of autoimmune disease, except for thyroid disease.
  • Have a history of lung inflammation or current lung issues.
  • Have low oxygen levels in the blood.
  • Require home oxygen.
  • Have uncontrolled health issues like recent heart attack or stroke, severe infection, heart failure, or mental health issues.
  • Have certain heart conditions based on an ECG test.
  • Have an active infection needing treatment.
  • Have HIV or hepatitis B or C.
  • Have another type of cancer, except for certain non-threatening cancers.
  • Have a gastrointestinal disease affecting medication absorption.
  • Have had gastrointestinal surgery affecting medication absorption.
  • Cannot take oral medication.
  • Cannot have blood drawn.
  • Have had surgery within 28 days before starting the study.
  • Have used certain medications affecting the study drugs within 28 days before starting the study.
  • Have fluid buildup in the abdomen needing treatment.
  • Have cancer invading the stomach or intestines.
  • Have an allergy to monoclonal antibodies.
  • Have an allergy to study drugs or their components.
  • Are pregnant or breastfeeding.
  • Are unable or unwilling to follow the study schedule.

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