Nivolumab for Eye
Phase-Based Progress Estimates
Effectiveness
Safety
Eye+1 More
Nivolumab - DrugEligibility
65+
All Sexes
What conditions do you have?
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Eligibility
65+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing whether nivolumab is a safe and effective treatment for a type of cancer called primary central nervous system lymphoma.
Eligible Conditions
- Eye
- Brain
Treatment Effectiveness
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: 2 years
2 years
Efficacy of Nivolumab
Overall Survival (OS)
Progression Free Survival (PFS)
Until up to 6 subjects can be adequately assessed for DLT.
Safety of Nivolumab in Older Subjects
approx. 2 years
Conversion Rate from Partial to Complete Response
Objective and Complete Response Rates
Trial Safety
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
Stage 1
1 of 2
Stage 2
1 of 2
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: Nivolumab · No Placebo Group · Phase 1
Stage 1
Drug
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: DrugStage 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
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Steven Park, MDLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,572 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,113 Previous Clinical Trials
1,129,649 Total Patients Enrolled
Eligibility Criteria
Age 65+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have PCNSL, CD20 positive by immunohistochemistry.
You have not previously received any therapy to treat your cancer.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
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