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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab; Vaccines

Criteria

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.

• 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.