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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    30
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 25 March 2022
cancer
pancreatic adenocarcinoma
folfirinox

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 .

Details
Condition Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Ductal Adenocarcinoma
Treatment Nivolumab, GVAX, Stereotactic Body Radiation (SBRT), CCR2/CCR5 dual antagonist
Clinical Study IdentifierNCT03767582
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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 our institution, the patient must agree to a research core biopsy to be performed at Johns 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 pancreatic adenocarcinoma
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 laboratory tests
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 patient is 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 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 into this 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 investigational agent or using an investigational device for the treatment of cancer
Current use of immunosuppressive medications within 14 days prior to study medications
Have received any vaccine within 14 days prior to study medications
Receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of the first dose of 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 angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
-lead electrocardiogram with QRS ≥ 120 msec, except right bundle branch block ; QTcF (QT corrected for heart rate using Fridericia's method) ≥ 480 msec, except right 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 bladder cancer, 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 study treatment
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 the first dose of BMS-813160
Prior use of Class I antiarrhythmics within 28 days of first dose of study medication
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 the study arm that participant is enrolling
Woman who are pregnant or breastfeeding
Patient is unwilling or unable to follow the study schedule for any reason
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