Study Summary
This trial is testing the long-term safety of a cancer drug.
Treatment Effectiveness
Study Objectives
7 Primary · 0 Secondary · Reporting Duration: From Day 1 up to 100 Days after discontinuation of treatment
Day 100
Incidence of AEs leading to Discontinuation
Incidence of Adverse Events (AEs)
Incidence of Immune-Mediated AEs
Incidence of Select AEs
Incidence of drug related AEs
Day 100
Incidence of Death
Incidence of Serious Adverse Events (SAEs)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
Trial Design
2 Treatment Groups
Nivolumab Dose 1
1 of 2
Nivolumab Dose 2
1 of 2
Experimental Treatment
800 Total Participants · 2 Treatment Groups
Primary Treatment: Nivolumab · No Placebo Group · Phase 2
Nivolumab Dose 1
Drug
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: DrugNivolumab Dose 2
Drug
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 up to 100 days after discontinuation of treatment
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,500 Previous Clinical Trials
3,927,202 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The participant is eligible for nivolumab treatment if they have completed the parent study or discontinued treatment, or have progressed on treatment, and are currently on or have completed the follow-up phase of the parent study.
People 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
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Conditions
Cancer Related
Treatments