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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

Must not have

Serious uncontrolled medical conditions requiring therapy

Subjects with CNS involvement and seizure activity in the past 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

My lymphoma is confirmed to be EBV-positive by a pathology lab.

Select...

My condition is Lymphomatoid granulomatosis grade I or II.

Select...

I have chronic active EBV disease affecting my B-cells or T-cells.

Select...

I have EBV-positive DLBCL linked to an immune system problem.

Select...

My lymphoma is EBV-positive.

Select...

I can provide a tissue sample or 15 slides of my tumor for study.

Select...

I am not pregnant and use birth control.

Select...

I have EBV-positive PTLD not related to solid organ transplant.

Select...

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.

Select...

I can understand and sign the consent form myself or have someone legally authorized to do so.

Select...

My condition is diagnosed as grade III Lymphomatoid granulomatosis.

Select...

My cancer can be measured or seen on tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious health condition that is not under control.

Select...

I have had seizures due to brain involvement in the last month.

Select...

I am HIV positive.

Select...

I have been treated with specific antibodies before.

Select...

My seizures are not controlled by medication.

Select...

I have active GVHD needing steroids or had severe acute or chronic GVHD.

Select...

I am currently receiving treatment for another cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL

Secondary study objectives

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 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220

0 / 21Eligibility criteria met