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An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first measure response approximately up to 25 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, BMS-986179, alone and with Nivolumab to see if they can shrink tumors in patients with advanced or spreading solid cancers. Both drugs aim to boost the immune system to better find and destroy cancer cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first measure response approximately up to 25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first measure response approximately up to 25 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
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Secondary study objectives
AUC (0-T)
AUC (Tau)
Cmax
+8 more

Side effects data

From 2021 Phase 1 & 2 trial • 235 Patients • NCT02754141
39%
Diarrhoea
22%
Anaemia
22%
Fatigue
22%
Pain
22%
Urinary tract infection
17%
Nausea
17%
Lipase increased
17%
Pain in extremity
17%
Headache
17%
Hypertension
17%
Constipation
17%
Decreased appetite
11%
Vomiting
11%
Lymphocyte count decreased
11%
Hypothyroidism
11%
Asthenia
11%
Oedema peripheral
11%
Neutrophil count increased
11%
Folate deficiency
11%
Hypophosphataemia
11%
Arthralgia
11%
Haematuria
11%
Pneumothorax
11%
Pruritus
11%
Rash
11%
Back pain
11%
Dizziness
11%
Pyrexia
11%
Gastrooesophageal reflux disease
11%
Cough
11%
Dyspnoea
6%
Rash maculo-papular
6%
Spinal cord compression
6%
Neoplasm progression
6%
Bacteraemia
6%
Sepsis
6%
Gamma-glutamyltransferase increased
6%
Stomatitis
6%
Laryngitis
6%
Blood creatinine increased
6%
Hemiparesis
6%
Pelvic pain
6%
Femoral neck fracture
6%
Malignant neoplasm progression
6%
Cerebrovascular accident
6%
Oral candidiasis
6%
Fall
6%
Blood creatine phosphokinase increased
6%
Protein total decreased
6%
Transaminases increased
6%
Myalgia
6%
Neck pain
6%
Productive cough
6%
Vertigo
6%
Abdominal pain
6%
Abdominal pain upper
6%
Dysphagia
6%
Face oedema
6%
Localised oedema
6%
Mucosal inflammation
6%
Bronchitis
6%
Infection
6%
Glycosylated haemoglobin increased
6%
Tri-iodothyronine free decreased
6%
Lipase decreased
6%
Lymphocyte percentage decreased
6%
Red blood cell sedimentation rate decreased
6%
White blood cell count increased
6%
White blood cells urine positive
6%
Hypomagnesaemia
6%
Iron deficiency
6%
Mobility decreased
6%
Paraesthesia
6%
Chromaturia
6%
Proteinuria
6%
Testis discomfort
6%
Pleural effusion
6%
Hypotension
6%
Infusion related reaction
6%
Blood alkaline phosphatase increased
6%
Monocyte count increased
6%
Hypercalcaemia
6%
Clubbing
6%
Urinary incontinence
6%
Dermatitis acneiform
6%
Haemorrhoids
6%
Chills
6%
Periodontitis
6%
Amylase decreased
6%
Blood creatine phosphokinase decreased
6%
Blood thyroid stimulating hormone increased
6%
Blood urea increased
6%
C-reactive protein increased
6%
Glomerular filtration rate decreased
6%
Urine leukocyte esterase positive
6%
Neutrophil percentage increased
6%
Red blood cells urine positive
6%
Dehydration
6%
Hyponatraemia
6%
Infected neoplasm
6%
Dysgeusia
6%
Hypoaesthesia
6%
Anxiety
6%
Insomnia
6%
Urinary retention
6%
Dysphonia
6%
Nasal congestion
6%
Dry skin
6%
Blood alkaline phosphatase decreased
6%
Blood urine present
6%
Hypoalbuminaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
P2 RCC Combo
P2 Monotherapy Unassigned
P2 Combo SCCHN
P2 Combo Melanoma
P2 Combo Prostate
P2 All Combo Therapy
P1A 150mg
P1A Combo Therapy 150mg
P1A Combo Therapy 300mg
P2 RCC Mono
P2 Combo Unassigned
P1A 600mg
P1A 1600mg
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
P1B All Combo
P1A 1200mg
P1A All Mono
P2 Combo NSCLC
P1A Combo Therapy 1200mg
P1A Combo Therapy 1600mg
P1B Combo Therapy 150mg
P1B BMS-986179 1600mg
P1A All Combo
P1B Combo Therapy BMS-986179 1200mg + Nivo360mg
P2 Combo Pancreatic
P2 RCC Crossover
ALL Combo (P1A+P1B+P2)
P1A 300mg
P1A Combo Therapy 600mg

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: Arm C-Combination TherapyExperimental Treatment2 Interventions
BMS-986179 + rHuPH20, dose as specified
Group II: Arm B- Combination TherapyExperimental Treatment2 Interventions
BMS-986179 + nivolumab, dose as specified
Group III: Arm A-MonotherapyExperimental Treatment1 Intervention
BMS-986179, dose as specified
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986179
2016
Completed Phase 2
~240
Nivolumab
2015
Completed Phase 3
~4010
rHuPH20
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,353 Total Patients Enrolled
~25 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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