Nivolumab for Eye

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Eye+1 More
Nivolumab - Drug
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

Effectiveness Progress

1 of 3

Other trials for Eye

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

Safety Progress

1 of 3

Other trials for Eye

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

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: Drug
Stage 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

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 preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

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.