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NCT05255601 | RECRUITING | Lymphoma, Non-Hodgkin

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma
Sponsor:

Bristol-Myers Squibb

Brief Summary:

The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.

Condition or disease

Lymphoma, Non-Hodgkin

Hodgkin Disease

Intervention/treatment

Relatlimab

Nivolumab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 68 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Actual Study Start Date : 2022-09-13
Estimated Primary Completion Date : 2028-07-05
Estimated Study Completion Date : 2028-07-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1or more lines of standard therapy.
  • * Participants with pathologically confirmed R/R NHL after non-response to or failure of 1or more lines of standard therapy, including, but not limited to, R/R primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL).
  • * Participants with pathologically confirmed R/R NHL after non-response to or failure of 2 or more lines of standard therapy, including Burkitt lymphoma (blast count \<25% malignant Burkitt cells and/or per the investigator's clinical assessment of risk status), lymphoblastic lymphoma (blast count \< 25% of marrow nucleated cells and/or per the investigator's clinical assessment of risk status), NK/T-cell lymphoma (nasal and non-nasal NK/T-cell lymphoma subtypes, but not aggressive NK/T-cell leukemia/lymphoma subtype).
  • * The participant's current disease state must be R/R to standard therapy.
  • * Participants must have measurable PET positive disease in both cHL and NHL cohorts.
Exclusion Criteria
  • * Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie, from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with leptomeningeal seeding.
  • * Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies.
  • * Prior treatment with lymphocyte activation gene-3 (LAG-3)-targeted agents.
  • * Participants with clinically significant systemic illnesses unrelated to the cancer as judged by the investigators, which would compromise the participant's ability to tolerate the study treatment.
  • * Participants with autoimmune disease.
  • * Prior allogeneic bone marrow transplantation.
  • Other protocol-defined inclusion/exclusion criteria apply
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma

Location Details

NCT05255601

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Albama

Local Institution - 0077

Birmingham, Albama, United States, 35233

RECRUITING

United States, Arizona

Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology

Phoenix, Arizona, United States, 85016

RECRUITING

United States, California

Lucile Packard Childrens Hospital - Stanford University

Palo Alto, California, United States, 94304

RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06510

WITHDRAWN

United States, Delaware

Local Institution - 0061

Wilmington, Delaware, United States, 19803

RECRUITING

United States, Florida

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States, 33908

WITHDRAWN

United States, Florida

Local Institution - 0017

Orlando, Florida, United States, 32804

WITHDRAWN

United States, Florida

St. Mary's Medical Center

West Palm Beach, Florida, United States, 33407

RECRUITING

United States, Maryland

The Johns Hopkins Hospital JHH

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Minnesota

University of Minnesota Medical School - Masonic Childrens Hospital

Minneapolis, Minnesota, United States, 55454

RECRUITING

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

WITHDRAWN

United States, Missouri

Local Institution - 0012

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute

Hackensack, New Jersey, United States, 07601

WITHDRAWN

United States, New York

Local Institution - 0016

Bronx, New York, United States, 10467

RECRUITING

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

RECRUITING

United States, New York

New York Medical College

Valhalla, New York, United States, 10595

WITHDRAWN

United States, Pennsylvania

Local Institution - 0019

Hershey, Pennsylvania, United States, 17033

WITHDRAWN

United States, Tennessee

Local Institution - 0014

Nashville, Tennessee, United States, 37232

NOT YET RECRUITING

United States, Texas

Local Institution - 0029

Austin, Texas, United States, 78723

RECRUITING

United States, Texas

CHRISTUS Childrens

San Antonio, Texas, United States, 78207

WITHDRAWN

United States, Virginia

Local Institution - 0076

Norfolk, Virginia, United States, 23507

WITHDRAWN

United States, Wisconsin

UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic

Madison, Wisconsin, United States, 53792

RECRUITING

Australia, New South Wales

University of New South Wales UNSW - Sydney Childrens Hospital SCH - The Centre for Cancer and Blood Disorders

Randwick, New South Wales, Australia, 2031

RECRUITING

Australia, Queensland

Royal Childrens Hospital RCH - Queensland Childrens Hospital

South Brisbane, Queensland, Australia, 4101

RECRUITING

Australia, Western Australia

Perth Childrens Hospital

Nedlands, Western Australia, Australia, 6009

RECRUITING

France, Angers Cedex 9

CHU dAngers - Pole Pediatrie

Angers, Angers Cedex 9, France, 49933

RECRUITING

France,

Pellegrin hospital group - Children's hospital

Bordeaux, France, 33076

NOT YET RECRUITING

France,

Local Institution - 0033

Caen, France, 14033

RECRUITING

France,

CHU Grenoble Alpes - Children's couple Hospital (HCE)

The face, France, 38700

RECRUITING

France,

Institute of hematology and pediatric oncology

Lyon, France, 69373 Cedex 08

WITHDRAWN

France,

Local Institution - 0034

Marseille, France, 13385

RECRUITING

France,

University hospital center of Montpellier CHU Montpellier - HOPITAL ARNAUD DE VILLENEUVE

Montpellier, France, 34295

RECRUITING

France,

Public assistance-hopitals of Paris (AP-HP)-Armand-Trousseau hospital

Paris, France, 75571

RECRUITING

France,

Public assistance-hopitals of Paris AP-HP-Robert-Debre university hospital

Paris, France, 75935

WITHDRAWN

France,

Local Institution - 0022

Rennes, France, 35203

RECRUITING

France,

CHRU of Strasbourg-Hopital de Hautepierre

Strasbourg, France, 67000

WITHDRAWN

Germany,

Local Institution - 0056

Aachen, Germany, 52074

WITHDRAWN

Germany,

Local Institution - 0015

Berlin, Germany, 13353

WITHDRAWN

Germany,

Local Institution - 0028

Pour, Germany, 35392

WITHDRAWN

Germany,

Local Institution - 0036

Hamburg, Germany, 20246

WITHDRAWN

Germany,

Local Institution - 0008

Muenster, Germany, 48149

WITHDRAWN

Germany,

Local Institution - 0051

Munich, Germany, 80337

NOT YET RECRUITING

Italy,

Local Institution - 0010

Avian, Italy, 33081

RECRUITING

Italy,

University Hospital of Bologna

Bologna, Italy, 40138

RECRUITING

Italy,

Meyer University Hospital

Florence, Italy, 50139

WITHDRAWN

Italy,

Local Institution - 0005

Genoa, Italy, 16147

RECRUITING

Italy,

IRCCS Foundation National Cancer Institute

Milano, Italy, 20133

NOT YET RECRUITING

Italy,

Local Institution - 0070

Milan, Italy, 20162

RECRUITING

Italy,

Mbbm Foundation - Pediatric clinic

Monza, Italy, 20900

WITHDRAWN

Italy,

Local Institution - 0013

Napoli, Italy, 80131

RECRUITING

Italy,

University Hospital Padua

Padova, Italy, 35128

NOT YET RECRUITING

Italy,

Local Institution - 0041

Pavia, Italy, 27100

RECRUITING

Italy,

Osp. Gesu child pediatric; IRCCS

Roma, Italy, 00165

RECRUITING

Italy,

A.O.U. City of Health and Science of Turin Infantile Hospital Regina Margherita

Turin, Italy, 10126

RECRUITING

Netherlands,

Princess Maxima Center for pediatric oncology

Utrecht, Netherlands, 3584 CS

RECRUITING

Spain, Barcelona

Hospital San Juan of God Barcelona

Esplugues de Llobregat, Barcelona, Spain, 08950

RECRUITING

Spain, Navarra

Clinic University of Navarra

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

WITHDRAWN

Spain,

Local Institution - 0009

Barcelona, Spain, 8026

RECRUITING

Spain,

Nino Jesus University Children's Hospital

Madrid, Spain, 28009

RECRUITING

Spain,

Clinic University of Navarra

Madrid, Spain, 28027

NOT YET RECRUITING

Spain,

Local Institution - 0044

Madrid, Spain, 28040

RECRUITING

Spain,

October 12 University Hospital

Madrid, Spain, 28041

RECRUITING

Spain,

La Paz University Hospital

Madrid, Spain, 28046

WITHDRAWN

Spain,

Local Institution - 0011

Santander, Spain, 39008

WITHDRAWN

Spain,

Local Institution - 0038

Sevilla, Spain, 41009

RECRUITING

Spain,

Virgen del Rocio Huvr University Hospital

Sevilla, Spain, 41013

RECRUITING

Spain,

Hospital University the Policenics The F

Valencia, Spain, 46026

RECRUITING

United Kingdom, Cambridgeshire

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

RECRUITING

United Kingdom, England

Alder Hey Children's NHS Foundation Trust

Liverpool, England, United Kingdom, L12 2AP

RECRUITING

United Kingdom, Londonderry

UCLH

London, Londonderry, United Kingdom, NW1 2PG

WITHDRAWN

United Kingdom, Nottinghamshire

Local Institution - 0003

Nottingham, Nottinghamshire, United Kingdom, NG5 1PB

WITHDRAWN

United Kingdom, Somerset

Local Institution - 0050

Bristol, Somerset, United Kingdom, BS2 8BJ

RECRUITING

United Kingdom, Tyne And Wear

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne And Wear, United Kingdom, Ne1 4lp

WITHDRAWN

United Kingdom, West Midlands

Local Institution - 0031

Birmingham, West Midlands, United Kingdom, Bch shnh

RECRUITING

United Kingdom,

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

London, United Kingdom, SM2 5pt