RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Nivolumab for Epstein-Barr Virus Infections

Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers.

Official registry: https://clinicaltrials.gov/study/NCT03258567 · National Cancer Institute (NCI) · enrollment listed as 40

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Nivolumab. The registry lists allocation as randomized. Background: The drug Nivolumab has been approved to treat some cancers.

They plan to enroll about 40 people at Bethesda. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas

Interventions: Nivolumab

Primary outcome (registry wording): overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL

Who it is for (from inclusion criteria)

Ages 12 Years to any
Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI
EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy
Lymphomatoid granulomatosis (LYG), grades I-II
Chronic active EBV disease (CAEBV) of B-cells or T-cells
EBV-positive post-transplantation lymphoproliferative disorder (PTLD)
NOTE: PTLD after solid organ transplantation is excluded. Patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible
EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same

Who the registry excludes

Subjects who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted
Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \>=grade II acute GVHD or extensive chronic GVHD
Subjects who have had solid organ transplant
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody
Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration

Public study contact (from the registry)

NCI Medical Oncology Referral Office

(240) 760-6050

ncimo_referrals@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.

NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia

Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT03258567 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03258567?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03258567?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary