Clinical Trials/NCT03767582

NCT03767582

Completed

Phase 1

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).

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country46 target enrollmentDecember 12, 2019

ConditionsLocally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma

InterventionsStereotactic Body Radiation (SBRT)Nivolumab CCR2/CCR5 dual antagonist GVAX

DrugsNivolumab CCR2/CCR5 dual antagonist GVAX

Overview

Phase: Phase 1
Intervention: Stereotactic Body Radiation (SBRT)
Conditions: Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 46
Locations: 1
Primary Endpoint: Number of Participants experiencing study drug-related toxicities
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .

Registry

clinicaltrials.gov

Start Date

December 12, 2019

End Date

February 1, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility 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.

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.

Arms & Interventions

Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist

Intervention: Stereotactic Body Radiation (SBRT)

Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist

Intervention: Nivolumab

Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist

Intervention: CCR2/CCR5 dual antagonist

Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist

Intervention: GVAX

Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist

Intervention: Stereotactic Body Radiation (SBRT)

Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist

Intervention: Nivolumab

Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist

Intervention: CCR2/CCR5 dual antagonist

Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist

Intervention: Stereotactic Body Radiation (SBRT)

Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist

Intervention: Nivolumab

Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist

Intervention: CCR2/CCR5 dual antagonist

Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist

Intervention: GVAX

Outcomes

Primary Outcomes

Number of Participants experiencing study drug-related toxicities

Time Frame: 3 years

Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0

Percentage of participants treated with immunotherapy who achieve an immune response

Time Frame: 3 years

Percentage of participants who have \>80% increase of infiltration of CD8+CD137+ T cells into the pancreatic ductal adenocarcinoma after treatment with immunotherapy compared to baseline before treatment.