Status:
COMPLETED
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
- 12-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.
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03767582
Start Date
December 12 2019
End Date
February 1 2025
Last Update
December 3 2025
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231