Nivolumab for Central Nervous System Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, NJCentral Nervous System LymphomaNivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether nivolumab can prevent recurrence of PCNSL in patients who have completed first-line treatment.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Nivolumab
1
Nivolumab
1
Nivolumab

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
cfDNA conversion rate in CSF
Day 60
Frequencies of toxicities

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Nivolumab
1
Nivolumab
1
Nivolumab

Side Effects for

Investigator Choice of Chemotherapy
57%Nausea
54%Anaemia
51%Fatigue
39%Decreased appetite
36%Malignant neoplasm progression
32%Constipation
31%Diarrhoea
30%Cough
29%Vomiting
29%Dyspnoea
25%Oedema peripheral
24%Back pain
21%Neutropenia
21%Pyrexia
19%Hypomagnesaemia
19%Headache
18%Arthralgia
16%Asthenia
16%Dizziness
16%Neutrophil count decreased
15%Thrombocytopenia
15%Insomnia
14%Weight decreased
14%Hyponatraemia
14%Rash
14%Platelet count decreased
13%Blood creatinine increased
13%White blood cell count decreased
12%Pain in extremity
12%Pruritus
12%Hypokalaemia
12%Abdominal pain
11%Alanine aminotransferase increased
11%Aspartate aminotransferase increased
11%Myalgia
10%Pneumonia
10%Muscular weakness
10%Productive cough
10%Alopecia
10%Dry skin
10%Chest pain
10%Hypoalbuminaemia
10%Dysgeusia
9%Abdominal pain upper
9%Mucosal inflammation
9%Hypothyroidism
9%Upper respiratory tract infection
9%Peripheral sensory neuropathy
8%Lacrimation increased
8%Non-cardiac chest pain
8%Nasopharyngitis
8%Dysphonia
8%Epistaxis
8%Haemoptysis
8%Stomatitis
7%Anxiety
7%Bronchitis
7%Dehydration
7%Hyperkalaemia
7%Hypertension
7%Chills
7%Blood alkaline phosphatase increased
7%Hyperglycaemia
7%Lymphocyte count decreased
6%Pneumonitis
6%Neuropathy peripheral
6%Oropharyngeal pain
6%Pleural effusion
6%Hypophosphataemia
6%Leukopenia
5%Dry mouth
5%Gamma-glutamyltransferase increased
5%Malaise
5%Urinary tract infection
5%Pain
5%Muscle spasms
5%Depression
5%Hypotension
5%Rash maculo-papular
5%Dyspepsia
5%Musculoskeletal chest pain
4%Fall
4%Pulmonary embolism
3%Myocardial infarction
3%Metastases to central nervous system
3%Musculoskeletal pain
3%Chronic obstructive pulmonary disease
3%Febrile neutropenia
2%Adrenal insufficiency
2%Atrial fibrillation
2%Sepsis
2%Malignant pleural effusion
2%Embolism
2%Cardiac failure
2%General physical health deterioration
1%Lung cancer metastatic
1%Neoplasm progression
1%Small intestinal haemorrhage
1%Gastrointestinal haemorrhage
1%Colitis
1%Appendicitis
1%Respiratory tract infection
1%Bone pain
1%Ataxia
1%Syncope
1%Bronchial obstruction
1%Pneumothorax
1%Circulatory collapse
1%Superior vena cava syndrome
1%Respiratory failure
1%Seizure
1%Pancytopenia
1%Atrial flutter
1%Pericardial effusion
1%Ileus
1%Small intestinal obstruction
1%Performance status decreased
1%Skin infection
1%Femur fracture
1%Hypercalcaemia
1%Cancer pain
1%Pericardial effusion malignant
1%Confusional state
1%Tumour pain
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the Investigator Choice of Chemotherapy ARM group. Side effects include: Nausea with 57%, Anaemia with 54%, Fatigue with 51%, Decreased appetite with 39%, Malignant neoplasm progression with 36%.

Trial Design

1 Treatment Group

Nivolumab Maintenance
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Nivolumab Maintenance
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: 12 months

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,847 Previous Clinical Trials
590,103 Total Patients Enrolled
4 Trials studying Central Nervous System Lymphoma
141 Patients Enrolled for Central Nervous System Lymphoma
Bristol-Myers SquibbIndustry Sponsor
2,514 Previous Clinical Trials
3,945,315 Total Patients Enrolled
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
255 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
33 Patients Enrolled for Central Nervous System Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to undergo lumbar puncture and/or Ommaya tap procedures without difficulty.
References

Frequently Asked Questions

Are there any open recruitment opportunities related to this clinical trial?

"Affirmative. Records hosted on clinicaltrials.gov attest that recruitment for this medical trial is ongoing, with 25 patients needed from seven sites since its posting in May of 2020 and subsequent updates in May 2022." - Anonymous Online Contributor

Unverified Answer

Is there a precedent for using Nivolumab in medical research?

"Nivolumab was initially studied in 2012 by a Local Institution. Currently, there are 718 active clinical trials, with many of them being hosted out of Middletown, New York; the total number of completed studies is 252." - Anonymous Online Contributor

Unverified Answer

How many participants are there in this clinical experiment?

"Affirmative, the information found on clinicaltrials.gov indicates that this research is now recruiting participants. First posted on May 22nd 2020 and last edited on May 6th 2022, the study plans to recruit 25 individuals from 7 trial sites." - Anonymous Online Contributor

Unverified Answer

How many geographic sites are currently administering this clinical trial?

"Currently, seven sites are recruiting patients for this clinical trial. These include Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale and Memorial Sloan Kettering Commack (Limited Protocol Activities), with an additional four centres involved." - Anonymous Online Contributor

Unverified Answer

Is this an unprecedented clinical trial?

"As of today, Nivolumab is being tested in 718 active clinical trials that span across 49 distinct countries and 2356 cities. The initial exploration into this medication began back in 2012 with Ono Pharmaceutical Co. Ltd sponsoring a study involving 659 patients; since then, 252 studies have been successfully concluded." - Anonymous Online Contributor

Unverified Answer

Could you elucidate the safety profile of Nivolumab?

"The safety of Nivolumab was rated two due to the Phase 2 status, suggesting that there is some evidence for its security but not yet any proof regarding efficacy." - Anonymous Online Contributor

Unverified Answer

To what medical conditions is Nivolumab typically prescribed?

"Nivolumab is most commonly used to treat cancerous tumours. However, it has also been successful in treating other ailments such as unresectable melanoma and metastatic esophageal adenocarcinoma." - 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.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top