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BMS-986258 + Nivolumab for Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Study 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.

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

Select...

My cancer returned or worsened after at least one standard treatment.

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of AEs leading to death

Incidence of AEs leading to discontinuation

Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria

+2 more

Secondary outcome measures

Serum

Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]

Concentration at the end of infusion (Ceoi)

+8 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Rash

14%

Hyponatraemia

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Dehydration

Hyperkalaemia

Hyperglycaemia

Chills

Blood alkaline phosphatase increased

Hypertension

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Femur fracture

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Neoplasm progression

Atrial flutter

Bronchial obstruction

Hypercalcaemia

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

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

2008

Completed Phase 2

~650

Nivolumab

2014

Completed Phase 3

~4750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,422 Total Patients Enrolled

Frequently Asked Questions

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

Is this the inaugural research effort in its field?

"There are 753 active clinical trials for BMS-986258 in 2499 cities spread across 57 nations. Ono Pharmaceutical Co. Ltd first sponsored the evaluation of this drug back in 2012, involving 659 test subjects and completing Phase 1 & 2 trial stages. Since then, 297 further investigations have been conducted concerning it's safety and efficacy."

Answered by AI

Could you please enumerate any other experiments involving BMS-986258 that have taken place?

"BMS-986258 was first investigated in 2012 at Local Institution. The total number of completed studies stands at 297, with 753 currently ongoing trials - many of which are taking place in Los Angeles, California."

Answered by AI

What maladies is BMS-986258 typically prescribed to alleviate?

"BMS-986258 is often prescribed to treat those afflicted with malignant neoplasms, but could also be beneficial for patients suffering from unresectable melanoma, squamous cell carcinoma, and drug extravasation."

Answered by AI

How widely distributed is this experiment?

"Currently, this experiment is enrolling participants at 20 medical centres across the United States. Locations include Los Angeles, Iowa City and Grand Rapids in addition to other sites. To make your involvement as easy as possible it's suggested that you select a clinic located near you."

Answered by AI

What is the current enrollment for this medical experiment?

"Unfortunately, the current clinical trial is not recruiting at this time. Originally posted on March 8th 2018 and last edited November 11th 2022, alternative studies may be of interest; 149 trials are actively seeking participants suffering from cancer while 753 studies have an open call for volunteers to join their BMS-986258 study."

Answered by AI

Is recruitment for participants still available in this experiment?

"Clinicaltrials.gov does not show that this medical trial is accepting any more participants, as it was first posted on March 8th 2018 and last updated November 11th 2022. Nonetheless, there are 902 other studies recruiting patients currently."

Answered by AI

Recent research and studies

Clinical Lymphoma Myeloma and LeukemiaJournal

Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma

El Halabi, Layal, Julien Adam, Pauline Gravelle, Virginie Marty, Alina Danu, Julien Lazarovici, Vincent Ribrag, et al.. 2021. “Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma”. Clinical Lymphoma Myeloma and Leukemia. Elsevier BV. doi:10.1016/j.clml.2020.11.009.

clinicaltrials.govStudy

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

2018. "An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03446040.

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