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Nivolumab + BMS-813160 +/- GVAX for Pancreatic Cancer

Phase 1 & 2
Recruiting
Led By Amol Narang, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0 or 1
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 not have
Any gastrointestinal surgery that is likely impact upon the absorption of study treatment
Unable to have blood drawn
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a combination of three drugs to treat patients with locally advanced pancreatic cancer. The goal is to see if the combination is safe and if it enhances the infiltration of CD8+CD137+ cells in pancreatic ductal adenocarcinomas (PDACs).

Who is the study for?
This trial is for adults over 18 with locally advanced pancreatic cancer that hasn't spread and can't be removed by surgery. They should have a life expectancy of more than 3 months, no prior treatments for their cancer, and must be able to take pills and undergo certain tests at Johns Hopkins. They need good organ function, agree to specific chemotherapy (FOLFIRINOX), radiation therapy only at Johns Hopkins, biopsies if needed, and use birth control.
What is being tested?
The study tests if combining nivolumab (an immunotherapy drug) with BMS-813160 (a CCR2/CCR5 dual antagonist) plus GVAX (a vaccine-based treatment) after chemo and radiotherapy is safe in patients with advanced pancreatic cancer. It also checks whether this combo increases immune cells' presence in the tumor.
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue or tiredness, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am willing to have a biopsy of my pancreatic cancer if surgery is not an option.
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My pancreatic cancer cannot be removed with surgery.
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I have not received any treatment for my advanced pancreatic cancer.
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My organs are functioning well according to specific lab tests.
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I am eligible for FOLFIRINOX-based chemotherapy.
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I am 18 years old or older.
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I am willing to receive radiation therapy exclusively at Johns Hopkins Hospital.
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I am willing to have a biopsy of my pancreatic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had stomach or intestine surgery that may affect how I absorb medication.
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I cannot have blood drawn for medical reasons.
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I do not have any severe illnesses or conditions that are not under control.
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I need treatment for fluid buildup in my abdomen.
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I am infected with HIV or hepatitis B or C.
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I am not pregnant or breastfeeding.
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I have had or currently have lung inflammation not caused by an infection.
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I had surgery less than 28 days before starting the study medication.
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I have had a stomach or intestine problem in the last 3 months that could affect how I absorb medication.
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My cancer has spread to my stomach or the beginning of my small intestine.
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I cannot take medicine by mouth.
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I am unable or unwilling to follow the study's schedule.
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I do not have any cancer except for certain skin, bladder, prostate, or cervical cancers.
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I have previously received immunotherapy for my condition.
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I have had a transplant of an organ, tissue, or bone marrow from another person.
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I need to use oxygen at home.
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I am currently being treated for an infection.
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I have received chemotherapy for pancreatic cancer that was not FOLFIRINOX.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants experiencing study drug-related toxicities
Immunotherapy
Secondary study objectives
Change in Quality of life score based on EORTC QLQ-C30/Pan26
Local progression free survival (LPFS) Time
Metastasis free survival (MFS)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonistExperimental Treatment4 Interventions
Group II: Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonistExperimental Treatment3 Interventions
Group III: Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonistExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation (SBRT)
2018
Completed Phase 2
~70
Nivolumab
2015
Completed Phase 3
~4010
GVAX
2015
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,686 Previous Clinical Trials
4,129,831 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,200 Total Patients Enrolled
Amol Narang, MDPrincipal InvestigatorJohns Hopkins Medical Institution
4 Previous Clinical Trials
79 Total Patients Enrolled

Media Library

BMS-813160 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03767582 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist, Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist, Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist
Pancreatic Cancer Clinical Trial 2023: BMS-813160 Highlights & Side Effects. Trial Name: NCT03767582 — Phase 1 & 2
BMS-813160 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03767582 — Phase 1 & 2
~0 spots leftby Dec 2024
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