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

Last updated: December 5, 2024
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Completed

Phase

1/2

Condition

Pancreatic Cancer

Pancreatic Disorders

Adenocarcinoma

Treatment

Stereotactic Body Radiation (SBRT)

CCR2/CCR5 dual antagonist

GVAX

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:
September 30, 2024

Connect with a study center

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21231
    United States

    Site Not Available

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