Nivolumab for Eye and Orbit

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Levine Cancer Institute, Charlotte, NC
Eye and Orbit+1 More
Nivolumab - Drug
Eligibility
65+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help prevent cancer from returning in patients who have had cancer in the past.

See full description

Eligible Conditions

  • Eye and Orbit
  • Brain and Nervous System

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Eye and Orbit

Study Objectives

This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Eye and Orbit. Measurement will happen over the course of Until up to 6 subjects can be adequately assessed for DLT..

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 and Orbit

Side Effects for

NIVOLUMAB 3 mg/kg
Fatigue
38%
Nausea
29%
Decreased appetite
28%
Cough
25%
Diarrhoea
25%
Dyspnoea
24%
Vomiting
20%
Constipation
19%
Anaemia
14%
Weight decreased
14%
Back pain
13%
Malignant neoplasm progression
13%
Arthralgia
13%
Pruritus
13%
Aspartate aminotransferase increased
13%
Pyrexia
12%
Rash
12%
Oedema peripheral
11%
Myalgia
10%
Productive cough
10%
Abdominal pain
10%
Dizziness
10%
Headache
9%
Non-cardiac chest pain
9%
Hypoalbuminaemia
9%
Alanine aminotransferase increased
9%
Hyponatraemia
9%
Asthenia
8%
Hypokalaemia
7%
Hypothyroidism
7%
Upper respiratory tract infection
7%
Musculoskeletal pain
7%
Hyperglycaemia
6%
Musculoskeletal chest pain
6%
Blood alkaline phosphatase increased
6%
Nasopharyngitis
6%
Pain in extremity
6%
Insomnia
6%
Haemoptysis
6%
Dry skin
6%
Dyspepsia
6%
Chills
6%
Lymphocyte count decreased
6%
Dysgeusia
5%
Hypomagnesaemia
5%
Rash maculo-papular
5%
Blood creatinine increased
4%
Pneumonia
4%
Muscular weakness
4%
Hypophosphataemia
3%
Stomatitis
3%
Chest pain
3%
Dysphonia
3%
Pneumonitis
3%
Mucosal inflammation
2%
Pulmonary embolism
2%
Peripheral sensory neuropathy
2%
Alopecia
2%
Pleural effusion
2%
Lung infection
2%
Pericardial effusion malignant
2%
Epistaxis
2%
Adrenal insufficiency
1%
Cancer pain
1%
Confusional state
1%
Pathological fracture
1%
Dehydration
1%
Respiratory failure
1%
Neutrophil count decreased
1%
Acute coronary syndrome
1%
Hypercalcaemia
1%
Chronic obstructive pulmonary disease
1%
Thrombocytopenia
1%
Syncope
1%
Neutropenia
1%
Infusion related reaction
1%
Pneumothorax
1%
Pulmonary haemorrhage
1%
Deep vein thrombosis
1%
Lacrimation increased
1%
Colitis
1%
General physical health deterioration
1%
Cholecystitis acute
1%
Hypersensitivity
1%
Sepsis
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Urinary tract infection
1%
Gamma-glutamyltransferase increased
1%
Metastases to central nervous system
1%
Lung neoplasm malignant
1%
Malignant pleural effusion
1%
Metastases to spine
1%
Tumour pain
1%
Cerebrovascular accident
1%
Seizure
1%
Renal failure
1%
Platelet count decreased
1%
White blood cell count decreased
1%
Diverticulitis
0%
Osteolysis
0%
Cholestasis
0%
Kyphosis postoperative
0%
Haemangioblastoma
0%
Aphasia
0%
Vascular occlusion
0%
Circulatory collapse
0%
Oesophagitis
0%
Metastases to meninges
0%
Epilepsy
0%
Haematuria
0%
Leukopenia
0%
Cataract
0%
Myocardial ischaemia
0%
Hepatic failure
0%
Influenza
0%
Spinal cord compression
0%
Pulmonary microemboli
0%
Embolism
0%
Iliac artery occlusion
0%
Death
0%
Bronchitis
0%
Localised infection
0%
C-reactive protein increased
0%
Haemoglobin decreased
0%
Presyncope
0%
Polyarthritis
0%
Mental status changes
0%
Bronchial obstruction
0%
Lumbar vertebral fracture
0%
Sinus bradycardia
0%
Radiation pneumonitis
0%
Hypoglycaemia
0%
Muscle spasticity
0%
Vocal cord paralysis
0%
Pulmonary oedema
0%
Suicide attempt
0%
Rash papular
0%
Cellulitis
0%
Haemothorax
0%
Mediastinal disorder
0%
Small intestinal obstruction
0%
Catheter site pain
0%
Appendicitis perforated
0%
Hepatitis
0%
Acute respiratory failure
0%
Pneumonia aspiration
0%
Aortic aneurysm rupture
0%
Vein disorder
0%
Upper gastrointestinal haemorrhage
0%
Pancytopenia
0%
Febrile neutropenia
0%
Atrial flutter
0%
Atrial fibrillation
0%
Acute left ventricular failure
0%
Cardiac arrest
0%
Cardiac failure
0%
Cardiac failure acute
0%
Cardiac failure congestive
0%
Myocardial infarction
0%
Cardiac tamponade
0%
Pericardial effusion
0%
Gastrointestinal haemorrhage
0%
Dysphagia
0%
Ileus
0%
Large intestinal obstruction
0%
Multiple organ dysfunction syndrome
0%
Performance status decreased
0%
Pain
0%
Appendicitis
0%
Erysipelas
0%
Peritonitis
0%
Respiratory tract infection
0%
Pneumonia bacterial
0%
Septic shock
0%
Skin infection
0%
Subcutaneous abscess
0%
Femur fracture
0%
Procedural complication
0%
Radiation necrosis
0%
Blood bilirubin increased
0%
Upper limb fracture
0%
Transaminases increased
0%
Bone pain
0%
Malignant melanoma
0%
Malignant neoplasm of spinal cord
0%
Non-small cell lung cancer
0%
Ataxia
0%
Depressed level of consciousness
0%
Loss of consciousness
0%
Psychotic disorder
0%
Atelectasis
0%
Eosinophilic pneumonia
0%
Pleuritic pain
0%
Superior vena cava syndrome
0%
Hypotension
0%
Jugular vein thrombosis
0%
Stevens-johnson syndrome
0%
Air embolism
0%
Peripheral artery thrombosis
0%
Fall
0%
Interstitial lung disease
0%
Acute kidney injury
0%
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 2
1 of 2
Stage 1
1 of 2
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Stage 2
Drug
Expansion Cohort
Stage 1
Drug
Safety Run-In
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
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Levine Cancer Institute - Charlotte, NC

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written informed consent and HIPAA authorization for release of personal health information of subject or subject's legally authorized representative.
Age ≥ 65 years at the time of consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 within 14 days prior to day 1 of treatment
Histological or cytological confirmation of PCNSL, CD20 positive by immunohistochemistry
Received at least 2 cycles of high-dose methotrexate (HD-MTX) containing induction chemotherapy per institutional standard (R-MPV preferred; see Appendix VI ) without evidence of progressive disease. HD-MTX is typically defined as a MTX dose of at least 3.0 g/m^2.
Recovered from all reversible acute toxic effects of prior therapy (other than alopecia) to ≤ Grade 1 or baseline)
Measurable disease at the time of diagnosis (i.e. prior to pre-study HD-MTX containing induction chemotherapy) including lesions that can be accurately measured in 2 dimensions by CT or MRI of brain and with a greatest transverse diameter of ≥ 1 cm. The following disease assessments must have been obtained prior to initiation of pre-study HD-MTX containing induction chemotherapy: MRI of the brain with contrast (and spine with contrast if indicated)
Deemed poor candidate for whole brain irradiation (WBI) or autologous stem cell transplant (ASCT) due to advanced age, ECOG performance status of 2, or in the opinion of the treating physician, subject would not tolerate the administration of WBI or ASCT for other reasons
Life expectancy of at least 3 months
Absolute Neutrophil Count (ANC) ≥ 1000K/mm3

Patient Q&A Section

How many people get eye and orbit a year in the United States?

"For ophthalmic surgeries, nearly all procedures are performed by elective surgery specialists, most frequently by general surgical procedures. Approximately 10,000 eye and orbital surgeries are performed in the United States of America each year. More than 70% of these procedures are performed by general surgical specialists. The number of surgeries performed by ophthalmologists/ orbital surgeons is significantly less than the number performed by optometrists or the number performed by general surgeons." - Anonymous Online Contributor

Unverified Answer

What are common treatments for eye and orbit?

"Different treatments exist depending on the specific patient and their underlying disease. Treatment is likely to be dependent on the type of tumor and how far it has progressed." - Anonymous Online Contributor

Unverified Answer

Can eye and orbit be cured?

"The current literature provides evidence that eye and orbital surgery is often curative. We do not have sufficient conclusive evidence for evidence-based consensus resolution for eye and orbital surgery to be considered curative." - Anonymous Online Contributor

Unverified Answer

What causes eye and orbit?

"Crowding of the eye by the mandible is a major risk factor for eye disease, as seen in trachoma, corneal opacities, and uveitis. Refractive errors could result from refractive surgery, including refractive errors caused by the mandible. Mandibular deviations caused by dental work. Other causes of eye disease include cataracts, glaucoma, retinopathy from diabetes, and uveitis. The main cause of eye and orbit disease (including refractive errors and trauma) is poor nutrition." - Anonymous Online Contributor

Unverified Answer

What is eye and orbit?

"The most common disorder encountered by primary care physicians is eye injury due to violence, followed by trauma to the orbit, periorbital sinus, and ear." - Anonymous Online Contributor

Unverified Answer

What are the signs of eye and orbit?

"Anterior uveitis is the leading cause of eye pain and blurred vision. Ocular pain and redness have been suggested as indications of ocular involvement in Graves' thye, but the diagnosis is primarily made on the basis of symptoms and examination findings. Miosis may be a sign of exophthalmos and proptosis or a sign of orbital perforation." - Anonymous Online Contributor

Unverified Answer

What is nivolumab?

"Nivolumab was associated with a slight increase in the cumulative hazard of SIE in patients with mCRC. This effect was similar regardless of T-Lineage Status and Tumor Suppressor Status." - Anonymous Online Contributor

Unverified Answer

What is the latest research for eye and orbit?

"The last decade is marked by a substantial number of publications concerning eye and orbital surgery and the development in new diagnostic and therapeutic ophthalmic surgical methods." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nivolumab?

"These ADME information can help inform on the prescribing of anti-PD-1 medications in clinical practice. Most of the ADME information on nivolumab showed the drugs as having few adverse effects. Most of the information related to the effects of nivolumab are the same for all antibodies. ADME information for antibodies such as abatacept, ixekizumab, or raxibacumab will also help guide on the patient's treatment." - Anonymous Online Contributor

Unverified Answer

Is nivolumab typically used in combination with any other treatments?

"The use of nivolumab with any treatment other than gemtuzumab ozogamicin resulted in more toxicities. Patients most likely to qualify for combination therapy are those who have undergone an autologous stem cell transplant and chemotherapy in the past, and are treated with nivolumab. Prospective cohorts of patients who are candidates for combination therapy are urgently needed to prevent unnecessary toxicity of nivolumab combined with chemotherapy." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for eye and orbit?

"Trial investigators should assess whether their work and clinical practice includes patients who may benefit from clinical trials and consider which clinical sites would be appropriate to participate in a trial of interest. They should also evaluate whether local ethics committees and their local regulatory authorities could be appropriate places for trial protocols to be developed and approved." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of eye and orbit?

"The primary cause of eye and orbital disease is [glaucoma] (50%). Other primary causes including hereditary disorders, trauma, intraoperative complications, uveitis, eye infections, [ocular cancer, and other tumours] accounted for another 25%. In some cases, ocular manifestations in one eye may indicate that the condition is on the way to developing in the second eye but it is also possible that it is just the patient exhibiting unilateral symptoms. When the cause is unknown, it is necessary to exclude a [disease process of the eye and its surrounding tissue] since this is also usually the case." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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