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Nivolumab Maintenance for Central Nervous System Lymphoma

Phase 2
Waitlist Available
Led By Christian Grommes, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
KPS ≥60
Patients must be able to tolerate lumbar punctures and/or Ommaya taps
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

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

Who is the study for?
Adults with primary central nervous system lymphoma (PCNSL) who still have tumor DNA in their spinal fluid after first-line treatment. They must be over 18, have a life expectancy of more than 3 months, and adequate organ function. Women must use birth control and have a negative pregnancy test; men also need to commit to using contraception.Check my eligibility
What is being tested?
The trial is testing Nivolumab as a maintenance therapy for PCNSL patients who've completed initial chemotherapy but still show tumor DNA in their spinal fluid. The goal is to see if Nivolumab can prevent the cancer from returning.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs, skin rash, hormone gland problems (like thyroid), diarrhea or colitis, liver inflammation, and lung issues like pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I can undergo spinal taps or Ommaya reservoir procedures.
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My blood counts and organ functions are within the required ranges for the study.
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My brain or spinal cord lymphoma diagnosis is confirmed, and I can provide tissue samples.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequencies of toxicities
cfDNA conversion rate in CSF

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab MaintenanceExperimental Treatment1 Intervention
All patients will undergo cerebrospinal fluid (CSF) and blood collection as well as MRI imaging as standard of care prior to (- 21 days) first-line treatment initiation, during first-line therapy (before initiation of the 5th methotrexate dose (+/- 7 days)), at completion of first-line chemotherapy therapy (+/- 7 days) as well as 60, 180, and 360 days after enrollment into maintenance or observation (+/- 7 days). Those patients with persistent cfDNA in the CSF after completion of first-line chemotherapy and either complete or partial response on imaging will be enrolled into the nivolumab maintenance treatment arm. All other patients (no persistent cfDNA in the CSF and either complete or partial response on imaging) are followed with observation. Patients who do not respond to first-line therapy are not eligible for nivolumab maintenance and will no longer be followed in the biospecimen and clinical data collection cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,606 Total Patients Enrolled
4 Trials studying Central Nervous System Lymphoma
161 Patients Enrolled for Central Nervous System Lymphoma
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,500 Total Patients Enrolled
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
228 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
33 Patients Enrolled for Central Nervous System Lymphoma

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT04401774 — Phase 2
Central Nervous System Lymphoma Research Study Groups: Nivolumab Maintenance
Central Nervous System Lymphoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04401774 — Phase 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401774 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy
2020. "Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04401774.
~5 spots leftby May 2026
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