What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, often cause side effects including nausea, vomiting, fatigue, hair loss, and increased risk of infection due to lowered blood cell counts. Nivolumab, a PD-1 inhibitor, can lead to immune-related adverse effects such as colitis, hepatitis, endocrinopathies, and pneumonitis. BMS-813160, a CCR2/CCR5 antagonist, is still under investigation, but potential side effects may include fatigue, gastrointestinal disturbances, and immune-related reactions. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and nab-paclitaxel. While there are no specific FDA approvals for a combination of a CCR2/CCR5 antagonist and a PD-1 inhibitor in pancreatic cancer, Nivolumab, a PD-1 inhibitor, has been approved for various cancers, including melanoma and non-small cell lung cancer. The combination of immunotherapy with chemotherapy, as seen in the trial with BMS-813160 and Nivolumab, represents an emerging area of research aimed at enhancing treatment efficacy for pancreatic cancer.

What other types of research exist?

Promising alternatives to BMS-813160 and Nivolumab for pancreatic cancer patients include: 1) Durvalumab (anti-PD-L1) with or without Tremelimumab (anti-CTLA-4), which has been evaluated for metastatic pancreatic ductal adenocarcinoma (mPDAC) and shown potential in clinical trials. 2) Combination therapy involving IL-6 blockade and PD-L1 inhibitors, which has demonstrated reduced tumor progression in murine models of pancreatic cancer.

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Other

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 below

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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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment (approximately 4 months) for reporting.

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 • NCT03496662

100%

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%

Paresthesia

14%

Dehydration

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%

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

2015

Completed Phase 3

~4010

Biopsy

2014

Completed Phase 4

~1150

0 / 18Eligibility criteria met

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.