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Checkpoint Inhibitor
Nivolumab for Lymphoma
Phase 2
Recruiting
Led By Christopher J Melani, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI
Subjects with Lymphomatoid granulomatosis (LYG) grades I-II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is testing if Nivolumab can slow the growth of some types of cancer or stop them from getting worse. It is also testing the safety of the drug.
Who is the study for?
This trial is for people aged 12 and older with EBV-positive lymphoproliferative disorders or non-Hodgkin lymphomas, who have no standard therapy options left. They should be at least two weeks out from previous treatments, have good organ function, and not be pregnant or breastfeeding. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Nivolumab's effectiveness in slowing down the growth of certain cancers linked to Epstein-Barr Virus that may not respond well to other treatments. It involves regular infusions of Nivolumab every two weeks along with frequent health checks and tests.See study design
What are the potential side effects?
Nivolumab can cause immune system-related side effects such as inflammation in various organs, potential infusion reactions like fever or chills, fatigue, skin issues, hormonal gland problems (like thyroid dysfunction), and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is confirmed to be EBV-positive by a pathology lab.
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My condition is Lymphomatoid granulomatosis grade I or II.
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I have chronic active EBV disease affecting my B-cells or T-cells.
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I have EBV-positive DLBCL linked to an immune system problem.
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My lymphoma is EBV-positive.
Select...
I can provide a tissue sample or 15 slides of my tumor for study.
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I am not pregnant and use birth control.
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I have EBV-positive PTLD not related to solid organ transplant.
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My EBV-positive B-cell NHL has not responded to or I can't have anthracycline and rituximab treatment.
Select...
I am 12 years old or older.
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I am between 12 and 18 years old and weigh at least 40 kilograms.
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I can understand and sign the consent form myself or have someone legally authorized to do so.
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My condition is diagnosed as grade III Lymphomatoid granulomatosis.
Select...
My cancer can be measured or seen on tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL
Secondary outcome measures
PFS of patients with EBV-LPD treated with nivolumab
duration of remission for patients who respond to nivolumab
overall survival of patients with EBV-LPD treated with nivolumab
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Hyponatraemia
14%
Rash
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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
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
2Treatment groups
Experimental Treatment
Group I: Nivolumab (B)Experimental Treatment1 Intervention
Nivolumab, 480 mg IV every 4 weeks for up to 2 years in subjects with responding disease with clinical benefit if they are tolerating treatment
Group II: Nivolumab (A)Experimental Treatment1 Intervention
Nivolumab, 3mg/kg IV every 2 weeks for up to 2 years in subjects with responding disease with clinical benefit if they are tolerating treatment (closed effective with activation of Amendment C)
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?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,926,093 Total Patients Enrolled
Christopher J Melani, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids or immunosuppressants in the last 14 days.I have a serious health condition that is not under control.I have had seizures due to brain involvement in the last month.I am HIV positive.I have EBV-positive lymphoproliferative disease, untreated or relapsed.I have EBV-positive DLBCL linked to an immune system problem.My lymphoma is EBV-positive.It has been at least 2 weeks since my last lymphoma treatment.It has been over 100 days since my last stem cell transplant or DLI.My organs and bone marrow are functioning well.I can provide a tissue sample or 15 slides of my tumor for study.I am not pregnant and use birth control.I have EBV-positive PTLD not related to solid organ transplant.My lymphoma is confirmed to be EBV-positive by a pathology lab.My condition is Lymphomatoid granulomatosis grade I or II.I have chronic active EBV disease affecting my B-cells or T-cells.My EBV-positive B-cell NHL has not responded to or I can't have anthracycline and rituximab treatment.I am 12 years old or older.I am between 12 and 18 years old and weigh at least 40 kilograms.I am physically able to perform daily activities.I can understand and sign the consent form myself or have someone legally authorized to do so.I have been treated with specific antibodies before.My condition is diagnosed as grade III Lymphomatoid granulomatosis.My seizures are not controlled by medication.My cancer can be measured or seen on tests.I have active GVHD needing steroids or had severe acute or chronic GVHD.I haven't had vaccines for infectious diseases in the last 4 weeks.I am currently receiving treatment for another cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab (A)
- Group 2: Nivolumab (B)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this clinical research?
"Affirmative. Clinicaltrials.gov data shows this medical experiment, initially posted on April 26th 2018, is actively searching for volunteers. 40 participants are required from 1 clinical centre."
Answered by AI
What therapeutic benefits does Nivolumab offer to patients?
"Nivolumab is typically used as a treatment for cancerous growths, but it can also be employed to manage unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinomas."
Answered by AI
Are there any vacancies remaining in this clinical investigation?
"According to the details found on clinicaltrials.gov, this experiment is still searching for volunteers. It was first posted in April of 2018 and its most recent update occurred in October 2022."
Answered by AI
What risks have been connected to the use of Nivolumab?
"Taking into account the current phase of clinical trials, there is some supporting evidence for the safety of Nivolumab and thus it has been assigned a rating of 2. However, this drug lacks data to support its efficacy as per Phase 2 regulations."
Answered by AI
Could you elaborate on any other research endeavors that have involved Nivolumab?
"As of now, there are 718 research studies going on that focus on Nivolumab. Of those, 82 have advanced to Phase 3. With primary trials located in Zürich, BE., there has been an impressive deployment with 40237 sites investigating this medication's efficacy."
Answered by AI
Has this trial been previously conducted with similar results?
"Currently, 718 active trials for Nivolumab are available in 2354 cities over 49 nations. This drug was first tested in a clinical trial back in 2012, sponsored by Ono Pharmaceutical Co. Ltd and included 659 participants to complete Phase 1 & 2 approvals. Since then, an additional 252 tests have been conducted."
Answered by AI
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