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Nivolumab Safety for Cancer

Phase 2
Recruiting
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 who have completed treatment with nivolumab, progressed on prior nivolumab treatment or discontinued nivolumab due to toxicity in the Parent Study are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival follow-up only.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the long-term safety of a cancer drug.

Who is the study for?
This trial is for cancer patients who have previously been treated with Nivolumab, either completed the treatment, experienced progression during it, or stopped due to side effects. They can join for long-term safety follow-up but not receive further Nivolumab unless deemed beneficial by the original study criteria.
What is being tested?
The main focus of this rollover study is to monitor the long-term safety of Nivolumab in participants who are currently receiving or have received it as part of an earlier 'Parent Study'. It involves observing these patients over time.
What are the potential side effects?
While specific side effects aren't listed here, typical ones associated with Nivolumab include fatigue, skin issues (like rash), problems with lung function (pneumonitis), and immune-related reactions affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not completed, progressed on, or stopped nivolumab due to side effects.

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%
Tinnitus
10%
Cushingoid
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

32Treatment groups
Experimental Treatment
Group I: E9: Cabozantinib MonotherapyExperimental Treatment1 Intervention
Group II: E8: Capecitabine MonotherapyExperimental Treatment1 Intervention
Group III: E7: Rucaparib MonotherapyExperimental Treatment1 Intervention
Group IV: E6: Sunitinib MonotherapyExperimental Treatment1 Intervention
Group V: E5: Enzalutamide MonotherapyExperimental Treatment1 Intervention
Group VI: E4: Leucovorin + Oxaliplatin + FluorouracilExperimental Treatment3 Interventions
Group VII: E3: Leucovorin + FluorouracilExperimental Treatment1 Intervention
Group VIII: E2: Regorafinib MonotherapyExperimental Treatment1 Intervention
Group IX: E1: Bevacizumab MonotherapyExperimental Treatment1 Intervention
Group X: E11: Pembrolizumab MonotherapyExperimental Treatment1 Intervention
Group XI: E10: Pemetrexed MonotherapyExperimental Treatment1 Intervention
Group XII: D4: Nivolumab + BevacizumabExperimental Treatment1 Intervention
Group XIII: D3: Nivolumab + DaratumumabExperimental Treatment2 Interventions
Group XIV: D2: Nivolumab + RucaparibExperimental Treatment2 Interventions
Group XV: D1: Nivolumab + TemozolomideExperimental Treatment2 Interventions
Group XVI: C9: Relatlimab + Nivolumab SAV + BevacizumabExperimental Treatment3 Interventions
Group XVII: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1Experimental Treatment2 Interventions
Group XVIII: C7: Relatlimab + Nivolumab SAV Dose 3Experimental Treatment2 Interventions
Group XIX: C6: Relatlimab + Nivolumab + CapecitabineExperimental Treatment2 Interventions
Group XX: C5: Relatlimab + Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group XXI: C4: Relatlimab + Nivolumab SAV Dose 2Experimental Treatment2 Interventions
Group XXII: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2Experimental Treatment1 Intervention
Group XXIII: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1Experimental Treatment2 Interventions
Group XXIV: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1Experimental Treatment1 Intervention
Group XXV: C12: Relatlimab + Nivolumab SAV Dose 5Experimental Treatment2 Interventions
Group XXVI: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2Experimental Treatment2 Interventions
Group XXVII: C10: Relatlimab + Nivolumab SAV Dose 4Experimental Treatment2 Interventions
Group XXVIII: B3: Nivolumab + Ipilimumab + TrametinibExperimental Treatment3 Interventions
Group XXIX: B2: Nivolumab + Ipilimumab + CabozantinibExperimental Treatment3 Interventions
Group XXX: B1: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group XXXI: A2: Nivolumab Monotherapy Dose 2Experimental Treatment1 Intervention
Group XXXII: A1: Nivolumab Monotherapy Dose 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Cabozantinib
2020
Completed Phase 2
~2360
Daratumumab
2014
Completed Phase 3
~2380
Enzalutamide
2014
Completed Phase 4
~3820
Capecitabine
2013
Completed Phase 3
~4280
Leucovorin
2005
Completed Phase 4
~6010
Fluorouracil
2014
Completed Phase 3
~11700
Ipilimumab
2015
Completed Phase 3
~3420
Relatlimab
2019
Completed Phase 2
~1150
Temozolomide
2010
Completed Phase 3
~1880
Pemetrexed
2014
Completed Phase 3
~5550
Pembrolizumab
2017
Completed Phase 3
~3130
Trametinib
2014
Completed Phase 2
~1630
Bevacizumab
2013
Completed Phase 4
~5540
Rucaparib
2016
Completed Phase 3
~2020
Oxaliplatin
2011
Completed Phase 4
~2890
Sunitinib
2014
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor
84 Previous Clinical Trials
203,765 Total Patients Enrolled
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,772,803 Total Patients Enrolled
ExelixisIndustry Sponsor
121 Previous Clinical Trials
18,658 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,097,571 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
9,531 Total Patients Enrolled

Media Library

Cancer Research Study Groups: E6: Sunitinib Monotherapy, D2: Nivolumab + Rucaparib, C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1, E4: Leucovorin + Oxaliplatin + Fluorouracil, B1: Nivolumab + Ipilimumab, D1: Nivolumab + Temozolomide, B3: Nivolumab + Ipilimumab + Trametinib, C10: Relatlimab + Nivolumab SAV Dose 4, C7: Relatlimab + Nivolumab SAV Dose 3, C9: Relatlimab + Nivolumab SAV + Bevacizumab, D3: Nivolumab + Daratumumab, D4: Nivolumab + Bevacizumab, E2: Regorafinib Monotherapy, E7: Rucaparib Monotherapy, E9: Cabozantinib Monotherapy, E11: Pembrolizumab Monotherapy, C5: Relatlimab + Nivolumab + Ipilimumab, E3: Leucovorin + Fluorouracil, A2: Nivolumab Monotherapy Dose 2, E1: Bevacizumab Monotherapy, C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2, C4: Relatlimab + Nivolumab SAV Dose 2, C12: Relatlimab + Nivolumab SAV Dose 5, A1: Nivolumab Monotherapy Dose 1, E8: Capecitabine Monotherapy, E5: Enzalutamide Monotherapy, B2: Nivolumab + Ipilimumab + Cabozantinib, C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1, C6: Relatlimab + Nivolumab + Capecitabine, C11: Relatlimab + Nivolumab SAV + PDCT Dose 2, E10: Pemetrexed Monotherapy, C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03899155 — Phase 2
Cancer Patient Testimony for trial: Trial Name: NCT03899155 — Phase 2
~700 spots leftby Aug 2029
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