Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.

Last updated: December 1, 2025
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Completed

Phase

1/2

Condition

Pancreatic Cancer

Digestive System Neoplasms

Pancreatic Disorders

Treatment

Stereotactic Body Radiation (SBRT)

CCR2/CCR5 dual antagonist

Nivolumab

Clinical Study ID

NCT03767582
J18163
IRB00190660
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years.

  • Patients with histologically- or cytologically-proven, surgically unresectable,locally advanced pancreatic adenocarcinoma.

  • If the patient does not have a diagnostic biopsy that is adequate for review at ourinstitution, the patient must agree to a research core biopsy to be performed atJohns Hopkins.

  • If the patient's available imaging is not adequate for review by our institution,the patient must agree to a repeat imaging to be performed at Johns Hopkins.

  • Patients cannot have had any prior therapy for the locally advanced pancreaticadenocarcinoma.

  • ECOG performance status 0 or 1

  • Life expectancy greater than 3 months.

  • Able to swallow pills or capsules.

  • Patient must have adequate organ function defined by the study-specified laboratorytests.

  • Patients must be eligible to receive FOLFIRINOX-based chemotherapy.

  • Patients must be willing to be treated with stereotactic body radiation therapy (SBRT) only at Johns Hopkins Hospital.

  • Patients must be willing to undergo a core biopsy of the pancreatic cancer.

  • Patients must be willing to undergo a biopsy of the pancreatic cancer if the patientis not deemed a surgical candidate during the pre-surgical evaluation.

  • Must use acceptable form of birth control while on study.

  • Ability to understand and willingness to sign a written informed consent document.

Exclusion

Exclusion Criteria:

  • Have had non-FOLFIRINOX-based chemotherapy for the pancreatic cancer.

  • Have received any anti-neoplastic biologics, vaccines or hormonal treatment,including investigational drugs, within 28 days of the first dose of study.

  • History of past treatment with immunotherapy agents prior to initial enrollment intothis study (including, but not limited to: IL-2, interferon, anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4 or anti-CCR2/5 drugs).

  • Have had prior organ or tissue allograft or allogeneic bone marrow transplantation,including corneal transplants.

  • Is currently participating or has participated in a study of an investigationalagent or using an investigational device for the treatment of cancer.

  • Current use of immunosuppressive medications within 14 days prior to studymedications.

  • Have received any vaccine within 14 days prior to study medications.

  • Receiving growth factors including, but not limited to, granulocyte-colonystimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of the first doseof study medication.

  • History of any autoimmune disease. Patients with thyroid disease will be allowed.

  • Has a history of (non-infectious) pneumonitis or current pneumonitis.

  • Has a pulse oximetry < 92% on room air.

  • Requires the use of home oxygen.

  • Patients with uncontrolled intercurrent illness including, but not limited to,myocardial infarction or stroke/transient ischemic attack within the past 6 months,uncontrolled infection, symptomatic congestive heart failure, unstable anginapectoris, cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit compliance with study requirements.

  • 12-lead electrocardiogram with QRS ≥ 120 msec, except right bundle branch block ;QTcF (QT corrected for heart rate using Fridericia's method) ≥ 480 msec, exceptright bundle branch block

  • Has an active infection requiring systemic therapy.

  • Infection with HIV or hepatitis B or C.

  • Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladdercancer, early stage prostate cancer, or carcinoma in situ of the cervix.

  • Current or recent (within 3 months of study treatment administration)gastrointestinal disease that could impact the absorption of study treatment.

  • Any gastrointestinal surgery that is likely impact upon the absorption of studytreatment.

  • Inability to tolerate oral medication.

  • Unable to have blood drawn.

  • Have had surgery within 28 days of the first dose of study medication.

  • Prior use of strong/moderate CYP3A4 inhibitors or inducers within 28 days of thefirst dose of BMS-813160.

  • Prior use of Class I antiarrhythmics within 28 days of first dose of studymedication.

  • Has ascites requiring medical management.

  • Presence of duodenal or gastric invasion by the tumor.

  • Hypersensitivity reaction to any monoclonal antibody.

  • Known allergy or hypersensitivity to study drugs or any of their components of thestudy arm that participant is enrolling.

  • Woman who are pregnant or breastfeeding.

  • Patient is unwilling or unable to follow the study schedule for any reason.

Study Design

Total Participants: 46
Treatment Group(s): 4
Primary Treatment: Stereotactic Body Radiation (SBRT)
Phase: 1/2
Study Start date:
December 12, 2019
Estimated Completion Date:
February 01, 2025

Connect with a study center

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore 4347778, Maryland 4361885 21231
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.