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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 100 days after completion of treatment (approximately 7.5 months)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 100 days after completion of treatment (approximately 7.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 100 days after completion of treatment (approximately 7.5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(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 outcome measures
(Part B and Part A Experimental Dose Level 0 Only): Overall Survival (OS)
(Part B and Part A Experimental Dose Level 0 Only): Percentage of Patients Whose Disease Becomes Resectable After Treatment
(Part B and Part A Experimental Dose Level 0 Only): Progression-free Survival (PFS)

Side effects data

From 2021 Phase 2 trial • 182 Patients • NCT02996110
38%
Constipation
34%
Fatigue
25%
Decreased appetite
25%
Nausea
25%
Cough
25%
Pruritus
22%
Rash
22%
Diarrhoea
22%
Arthralgia
22%
Back pain
16%
Pain in extremity
16%
Malignant neoplasm progression
16%
Pyrexia
16%
Myalgia
13%
Anaemia
13%
Upper respiratory tract infection
13%
Abdominal pain
13%
Flank pain
13%
Paraesthesia
13%
Oedema peripheral
13%
Dizziness
9%
Pneumonia
9%
Night sweats
9%
Stomatitis
9%
Dry eye
9%
Chills
9%
Gastroenteritis
9%
Non-cardiac chest pain
9%
Hypercalcaemia
9%
Dyspnoea
6%
Gait disturbance
6%
Dry skin
6%
Hyponatraemia
6%
Aspartate aminotransferase increased
6%
Hypoalbuminaemia
6%
Muscular weakness
6%
Epigastric discomfort
6%
Oral pain
6%
Vomiting
6%
Asthenia
6%
Influenza
6%
Fall
6%
Weight decreased
6%
Hyperkalaemia
6%
Amnesia
6%
Hypotension
6%
Rhinorrhoea
3%
Dyspnoea exertional
3%
Hypomagnesaemia
3%
Wound infection
3%
Alanine aminotransferase increased
3%
Tremor
3%
Lipase increased
3%
Pulmonary embolism
3%
Oropharyngeal pain
3%
Polymyalgia rheumatica
3%
Gastrointestinal haemorrhage
3%
Cholecystitis
3%
Wound dehiscence
3%
Blood alkaline phosphatase increased
3%
Tumour pain
3%
Spinal cord compression
3%
Pleural effusion
3%
Haematoma
3%
Sinus tachycardia
3%
Dry mouth
3%
Chest discomfort
3%
Mucosal inflammation
3%
Procedural pain
3%
Amylase increased
3%
Hyperglycaemia
3%
Hypokalaemia
3%
Hypophosphataemia
3%
Neck pain
3%
Headache
3%
Insomnia
3%
Pollakiuria
3%
Urinary retention
3%
Pleuritic pain
3%
Productive cough
3%
Erythema
3%
Palmar-plantar erythrodysaesthesia syndrome
3%
Hypertension
3%
Vertigo
3%
Adrenal insufficiency
3%
Gastrooesophageal reflux disease
3%
Muscle spasms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Track 2: Nivolumab Plus Relatlimab (BMS-986016)
Track 1: Nivolumab Plus Relatlimab (BMS-986016)
Track 2: Nivolumab Plus BMS-813160 300 mg
Track 2: Nivolumab Plus BMS-986205
Track 2: Nivolumab Plus BMS-813160 150 mg
Track 2: Nivolumab Plus Ipilimumab (BMS-734016)
Track 1: Nivolumab Plus Ipilimumab (BMS-734016)

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
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Peripheral blood
2018
Completed Phase 1
~70
BMS-813160
2010
Completed Phase 2
~590
Nivolumab
2014
Completed Phase 3
~4750
Biopsy
2014
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,685 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,468 Total Patients Enrolled
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,741 Total Patients Enrolled

Media Library

BMS-813160 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03496662 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Part B - Dose expansion, Part A - Experimental Dose Level 0, Part A - Control (chemotherapy only)
Pancreatic Cancer Clinical Trial 2023: BMS-813160 Highlights & Side Effects. Trial Name: NCT03496662 — Phase 1 & 2
BMS-813160 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496662 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have been done to explore the potential of BMS-813160?

"At present, there are 1770 clinical investigations of BMS-813160 with 388 trials in their final stage. Despite the fact that Shanghai holds a number of these studies, it is estimated that 92300 sites across the world are currently conducting research into this drug."

Answered by AI

What diseases does BMS-813160 commonly target?

"BMS-813160 is the primary drug used to treat malignant neoplasms, yet it can also be employed in cases of unresectable melanoma and other cancers such as squamous cell carcinoma and non-small cell lung carcinoma."

Answered by AI

Is recruitment for this research currently open?

"According to clinicaltrials.gov, this experiment is not currently on the hunt for participants; although it was initially posted in August 2018 and last edited in November 2022, no new candidates are being sought at present. Fortunately, there are 2571 other studies actively enrolling patients right now."

Answered by AI

How many participants have been enrolled in this medical study?

"Presently, this trial is not gathering new participants. It was initially listed on August 31st 2018 and last updated on November 10th 2022. If you are searching for other trials, there are 801 clinical studies enrolling people with adenocarcinoma as well as 1770 investigations concerning BMS-813160 that are actively recruiting."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
2018. "BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03496662.
~6 spots leftby Apr 2025
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