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BMS-986258 + Nivolumab for Cancer

Lebanon, NH
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
Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Must not have
Active, known or suspected autoimmune disease
Other active malignancy requiring concurrent intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective when used alone or with another cancer drug.

See full description
Who is the study for?
This trial is for adults with certain advanced cancers (kidney, colorectal, lung, head and neck, or triple-negative breast cancer) that have spread or can't be removed by surgery. Participants must have tried at least one standard treatment without success and should be in good physical condition. Women of childbearing potential must agree to use contraception.Check my eligibility
What is being tested?
The study is testing the safety and tolerability of BMS-986258 alone and when combined with Nivolumab in treating advanced cancers. It aims to see how well these therapies work on their own or together against different solid tumors.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to immunotherapy agents like skin issues, gut inflammation causing diarrhea, liver inflammation leading to fatigue or jaundice, hormonal gland problems affecting energy levels, as well as common infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer returned or worsened after at least one standard treatment.
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I am fully active or can carry out light work.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease.
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I have another cancer that needs treatment at the same time.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part C Cohort Expansion: BMS-986258 + nivolumabExperimental Treatment2 Interventions
Group II: Part B Dose Escalation: BMS-986258 + nivolumabExperimental Treatment2 Interventions
Group III: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)Experimental Treatment2 Interventions
Group IV: Part A Dose Escalation: BMS-986258Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rHuPH20
2018
Completed Phase 3
~1360
Nivolumab
2014
Completed Phase 3
~3880

Find a Location

Closest Location:Local Institution· Lebanon, NH

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,727 Previous Clinical Trials
4,128,677 Total Patients Enrolled
~11 spots leftby Mar 2026
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