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Checkpoint Inhibitor

BMS-936558 for Blood Cancers

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 dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (up to approximately 95 months)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug for people with B-cell cancer that has come back or does not respond to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (up to approximately 95 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (up to approximately 95 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
Duration of Response (DoR) - Part D
Number of Participants Who Died
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
+2 more
Secondary outcome measures
BMS-986016 Accumulation Index (AI_AUC)
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
BMS-986016 Average Concentration Over a Dosing Interval ([AUC(TAU)/Tau] (Css,Avg)
+10 more

Side effects data

From 2020 Phase 3 trial • 405 Patients • NCT01721746
51%
Fatigue
42%
Nausea
30%
Anaemia
29%
Alopecia
24%
Neutropenia
24%
Vomiting
23%
Constipation
21%
Arthralgia
21%
Decreased appetite
18%
Malignant neoplasm progression
18%
Diarrhoea
14%
Dyspnoea
13%
Abdominal pain
13%
Pain in extremity
13%
Paraesthesia
11%
Thrombocytopenia
11%
Neuropathy peripheral
11%
Asthenia
11%
Headache
10%
Pyrexia
10%
Leukopenia
10%
Myalgia
9%
Infusion related reaction
9%
Platelet count decreased
9%
White blood cell count decreased
8%
Neutrophil count decreased
8%
Weight decreased
8%
Cough
6%
Aspartate aminotransferase increased
6%
Abdominal pain upper
6%
Depression
6%
Insomnia
6%
Rash
5%
Oedema peripheral
5%
Dizziness
4%
Urinary tract infection
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Alanine aminotransferase increased
4%
Dyspepsia
4%
Influenza like illness
4%
Pain
4%
Hypertension
3%
Dysgeusia
3%
Dry mouth
3%
Chills
3%
Blood alkaline phosphatase increased
3%
Hyperkalaemia
3%
Neck pain
3%
Dry skin
2%
Back pain
2%
Upper respiratory tract infection
2%
Acute kidney injury
2%
Febrile neutropenia
2%
Pleural effusion
2%
Blood creatinine increased
2%
Pruritus
2%
Rash maculo-papular
2%
Hyponatraemia
1%
Food poisoning
1%
Toxicity to various agents
1%
Cellulitis
1%
Muscle spasms
1%
Cancer pain
1%
Embolism arterial
1%
Small intestinal perforation
1%
Incoherent
1%
Transient ischaemic attack
1%
Febrile bone marrow aplasia
1%
Myocardial infarction
1%
Colitis
1%
Multiple organ dysfunction syndrome
1%
Erysipelas
1%
Febrile infection
1%
Localised infection
1%
Neutropenic sepsis
1%
Femur fracture
1%
Hypoglycaemia
1%
Flank pain
1%
Malignant melanoma
1%
Metastases to central nervous system
1%
Cerebrovascular accident
1%
Skin haemorrhage
1%
Hypotension
1%
Peripheral embolism
1%
Hyperglycaemia
1%
Hypoalbuminaemia
1%
Anxiety
1%
Vitiligo
1%
Skin neoplasm bleeding
1%
Tumour associated fever
1%
Neoplasm progression
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Nivolumab

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part D - relatlimab + nivolumab (Cohort expansion)Experimental Treatment2 Interventions
Group II: Part C - relatlimab + nivolumab (Dose escalation)Experimental Treatment2 Interventions
Group III: Part B - relatlimab (Cohort expansion)Experimental Treatment1 Intervention
Group IV: Part A - relatlimab (Dose escalation)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986016
2018
Completed Phase 2
~130
BMS-936558
2012
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,634 Previous Clinical Trials
4,126,749 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
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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
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
2014. "A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02061761.
~10 spots leftby Apr 2025
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