← Back to Search

Checkpoint Inhibitor

BMS-936558 for Hematopoietic Stem Cell Transplantation for Pediatric Hematological Malignancies

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
No Placebo-Only Group

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.

Eligible Conditions
  • Hematopoietic Stem Cell Transplantation for Pediatric Hematological Malignancies
  • Blood Cancers

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
50%
Fatigue
34%
Nausea
34%
Diarrhoea
32%
Malignant neoplasm progression
28%
Arthralgia
27%
Pruritus
27%
Cough
24%
Anaemia
21%
Back pain
21%
Vomiting
21%
Rash
20%
Constipation
20%
Decreased appetite
19%
Pyrexia
19%
Dyspnoea
19%
Abdominal pain
18%
Headache
16%
Oedema peripheral
14%
Aspartate aminotransferase increased
14%
Pain in extremity
13%
Asthenia
13%
Insomnia
12%
Myalgia
12%
Vitiligo
12%
Musculoskeletal pain
11%
Alanine aminotransferase increased
11%
Dizziness
10%
Nasopharyngitis
10%
Pain
10%
Hypothyroidism
9%
Upper respiratory tract infection
9%
Urinary tract infection
9%
Hyponatraemia
9%
Weight decreased
9%
Dry skin
8%
Dyspepsia
8%
Blood alkaline phosphatase increased
8%
Rash maculo-papular
8%
Hypertension
8%
Abdominal pain upper
7%
Chills
7%
Influenza like illness
7%
Anxiety
7%
Blood creatinine increased
7%
Hypoalbuminaemia
6%
Muscle spasms
6%
Hypokalaemia
6%
Dysgeusia
6%
Hypocalcaemia
6%
Neck pain
5%
Dry mouth
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Paraesthesia
4%
Platelet count decreased
4%
Neuropathy peripheral
3%
Alopecia
3%
Depression
3%
Thrombocytopenia
3%
White blood cell count decreased
3%
Pneumonia
3%
Metastatic malignant melanoma
2%
General physical health deterioration
2%
Malignant melanoma
2%
Dehydration
1%
Infusion related reaction
1%
Lipase increased
1%
Hypotension
1%
Cancer pain
1%
Cerebrovascular accident
1%
Prostate cancer
1%
Cellulitis
1%
Femur fracture
1%
Hydronephrosis
1%
Squamous cell carcinoma
1%
Ventricular arrhythmia
1%
Gastrointestinal haemorrhage
1%
Pancreatitis
1%
Metastases to adrenals
1%
Pleural effusion
1%
Haemorrhage intracranial
1%
Seizure
1%
Confusional state
1%
Renal failure
1%
Haemoptysis
1%
Hypoxia
1%
Pneumonitis
1%
Pulmonary embolism
1%
Embolism
1%
Leukopenia
1%
Neutropenia
1%
Cardiac arrest
1%
Colitis
1%
Small intestinal obstruction
1%
Hepatitis
1%
Erysipelas
1%
Sepsis
1%
Liver function test increased
1%
Osteoarthritis
1%
Pathological fracture
1%
Tumour fistulisation
1%
Tumour pain
1%
Metastatic pain
1%
Lymphadenopathy
1%
Adrenal insufficiency
1%
Atrial fibrillation
1%
Atrial flutter
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nivolumab
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

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 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
2,682 Previous Clinical Trials
4,124,915 Total Patients Enrolled
~9 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top