Loading clinical trials...

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

COMPLETEDPHASE1/PHASE2

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

A Phase I/II Trial of Combination Immunotherapy With Nivolumab and a CCR2/CCR5 Dual Antagonist (BMS-813160) With or Without GVAX Following Chemotherapy and Radiotherapy for Locally Advanced Pancreatic Ductal Adenocarcinomas (PDACs).

NCT03767582•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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.
+20 more criteria

Locations (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

December 12, 2019

Primary Completion Date

February 1, 2025

Completion Date

February 1, 2025

Last Updated

December 3, 2025

Enrollment

ACTUAL participants

Conditions

Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma

Interventions

Stereotactic Body Radiation (SBRT)

RADIATION

Nivolumab

DRUG

CCR2/CCR5 dual antagonist

DRUG

GVAX

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

RECRUITINGPHASE1/PHASE2

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

NCT06445062

Colorectal CancerCRC+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors