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BMS-813160 + Nivolumab + Chemotherapy for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Kian-Huat Lim, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal bone marrow and organ function as defined below
At least 18 years of age
Must not have
Current or recent gastrointestinal disease or conditions that could interfere with the swallowing or absorption of study medication
History of allogeneic organ or stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of treatment (approximately 4 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new combination of four drugs to treat pancreatic cancer. It aims to see if combining immune-boosting and cancer-killing drugs can improve treatment outcomes.
Who is the study for?
Adults with locally advanced or borderline resectable pancreatic ductal adenocarcinoma, who haven't had prior chemotherapy or radiation for this disease. They must have good organ function and blood counts, not be on immunosuppressants, agree to use two forms of contraception if applicable, and sign a consent form. Exclusions include those with certain heart diseases, recent major surgeries, active infections requiring therapy, known HIV or hepatitis B/C infection.
What is being tested?
The trial is testing a new drug combination for treating pancreatic cancer: BMS-813160 with nivolumab (an immune system booster), gemcitabine and nab-paclitaxel (chemotherapy drugs). The study aims to evaluate the side effects and how well the disease responds to this treatment regimen.
What are the potential side effects?
Potential side effects may include reactions related to the immune system's enhancement such as inflammation in various organs; typical chemotherapy-related issues like nausea, fatigue, hair loss; increased risk of infections due to lowered immunity; possible allergic reactions similar to other compounds in the drugs' class.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bone marrow and organs are functioning normally.
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I am 18 years old or older.
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I am fully active and can carry on all my pre-disease activities without restriction.
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All my side effects from previous cancer treatments have mostly gone away.
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My pancreatic cancer is advanced but might be removable with surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no stomach or intestine problems affecting my medication absorption.
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I have had an organ or stem cell transplant from a donor.
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I have not had chemotherapy or radiation for my current illness before this trial.
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I do not have serious heart problems.
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I have not had major surgery in the last 4 weeks.
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I am not taking any medications or eating foods that could affect the trial medication.
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I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.
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I have another cancer that needs treatment at the same time.
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I have a history of hepatitis B or currently have hepatitis C.
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I have tested positive for HIV or have AIDS.
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I must keep taking warfarin for blood thinning and cannot switch to another medication.
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My cancer is not squamous, adenosquamous, or a neuroendocrine tumor.
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I have been treated with specific antibodies before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of treatment (approximately 4 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of treatment (approximately 4 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
(Part B and Part A Experimental Dose Level 0 Only): Objective Response Rate
Secondary study objectives
(Part B and Part A Experimental Dose Level 0 Only): Overall Survival (OS)
(Part B and Part A Experimental Dose Level 0 Only): Progression-free Survival (PFS)
Side effects data
From 2024 Phase 1 & 2 trial • 40 Patients • NCT03496662100%
Anemia
100%
Alopecia
100%
Platelet count decreased
86%
White blood cell decreased
86%
Fatigue
86%
Nausea
86%
Aspartate aminotransferase increased
86%
Alanine aminotransferase increased
71%
Peripheral sensory neuropathy
71%
Edema limbs
71%
Anorexia
71%
Alkaline phosphatase increased
71%
Hypoalbuminemia
71%
Cough
71%
Neutrophil count decreased
57%
Hyperglycemia
57%
Hypokalemia
57%
Dizziness
57%
Epistaxis
57%
Lymphocyte count decreased
43%
Constipation
43%
Diarrhea
43%
Vomiting
43%
Chills
43%
Fever
43%
Myalgia
43%
Rash maculo-papular
43%
Hypertension
29%
Arthralgia
29%
Pain in extremity
29%
Abdominal pain
29%
Mucositis oral
29%
Sweating
29%
Gallbladder infection
29%
Hyponatremia
29%
Headache
29%
Tremor
29%
Dyspnea
29%
Hypotension
29%
Creatinine increased
29%
Hypocalcemia
29%
Nail discoloration
29%
Sinus bradycardia
14%
Dehydration
14%
Paresthesia
14%
Upper gastrointestinal hemorrhage
14%
Vertigo
14%
Hemorrhoids
14%
Foot pain
14%
Upper respiratory infection
14%
Cholangitis
14%
Sepsis
14%
Bruising
14%
Infusion related reaction
14%
Wound dehiscence
14%
Activated partial thromboplastin time prolonged
14%
Back pain
14%
Dysgeusia
14%
Acute kidney injury
14%
Hematuria
14%
Proteinuria
14%
Vaginal bleeding
14%
Depression
14%
Insomnia
14%
Hoarseness
14%
Nasal congestion
14%
Pneumonitis
14%
Dermatitis
14%
Nail ridging
14%
Pruritus
14%
Skin hyperpigmentation
14%
Thromboembolic event
14%
Cholecystitis
14%
Gallbladder obstruction
14%
Leukocytosis
14%
Chest swelling
14%
Dysuria
14%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A - Experimental Dose Level 0
Part A - Control (Chemotherapy Only)
Part B - Dose Expansion
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
Active Control
Group I: Part B - Dose expansionExperimental Treatment6 Interventions
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
Group II: Part A - Experimental Dose Level 0Experimental Treatment6 Interventions
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cyclesore cycles
Group III: Part A - Control (chemotherapy only)Active Control4 Interventions
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Nab-paclitaxel
2014
Completed Phase 3
~1950
Peripheral blood
2018
Completed Phase 2
~110
BMS-813160
2018
Completed Phase 2
~680
Nivolumab
2014
Completed Phase 3
~5220
Biopsy
2014
Completed Phase 4
~1090
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. BMS-813160, a CCR2/CCR5 antagonist, works by blocking the CCR2 and CCR5 receptors on immune cells, which can reduce tumor-promoting inflammation and inhibit the recruitment of immunosuppressive cells to the tumor microenvironment.
Nivolumab, a PD-1 inhibitor, prevents the PD-1 protein on immune cells from binding to PD-L1 on cancer cells, thereby enhancing the immune system's ability to attack the tumor. These mechanisms are crucial for pancreatic cancer patients as they can potentially improve the immune system's ability to recognize and destroy cancer cells, offering a new avenue for treatment in a cancer type that is often resistant to conventional therapies.
Promising new therapies in advanced pancreatic adenocarcinomas.
Promising new therapies in advanced pancreatic adenocarcinomas.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,985 Previous Clinical Trials
2,291,960 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,125,393 Total Patients Enrolled
The Foundation for Barnes-Jewish HospitalOTHER
40 Previous Clinical Trials
6,382 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no stomach or intestine problems affecting my medication absorption.I do not have any uncontrolled illnesses or infections needing treatment within the last week.I have had an organ or stem cell transplant from a donor.I have not had chemotherapy or radiation for my current illness before this trial.My bone marrow and organs are functioning normally.I am 18 years old or older.I am fully active and can carry on all my pre-disease activities without restriction.All my side effects from previous cancer treatments have mostly gone away.I haven't taken steroids or immunosuppressants in the last 14 days.I have lung disease that causes symptoms or could affect lung treatment.I do not have serious heart problems.I have not had major surgery in the last 4 weeks.I am not taking any medications or eating foods that could affect the trial medication.My pancreatic cancer is advanced but might be removable with surgery.I am suspected to have pancreatic cancer and will confirm it with a biopsy before treatment.I have lasting side effects from previous cancer treatments, like nerve pain.I agree to use two forms of birth control during and up to 5/7 months after the study.My doctor agrees a tumor biopsy is too risky for me.I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.I have another cancer that needs treatment at the same time.I am currently on immune system modifying drugs but can stop for the trial.I have a history of hepatitis B or currently have hepatitis C.I have tested positive for HIV or have AIDS.I must keep taking warfarin for blood thinning and cannot switch to another medication.My cancer is not squamous, adenosquamous, or a neuroendocrine tumor.I have been treated with specific antibodies before.
Research Study Groups:
This trial has the following groups:- Group 1: Part B - Dose expansion
- Group 2: Part A - Experimental Dose Level 0
- Group 3: Part A - Control (chemotherapy only)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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