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

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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 Identifier	NCT03767582
Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on	25 March 2022

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