Nivolumab for Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
CancerNivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

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: Drug
Nivolumab Dose 2
Drug
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: Drug
Treatment
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