RECRUITING

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

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Conditions

Lymphoma, Non-HodgkinHodgkin DiseasePediatricRelatlimabNivolumabLymphocyte Activation Gene-3Lymphoma, Large B-Cell, DiffusePrimary Mediastinal B-cell LymphomaLymphoma, Large-Cell, AnaplasticBurkitt lymphomaLymphoblastic lymphomaNK/ T-cell lymphomaPeripheral T-cell lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-13
Study Completion:2028-07-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05255601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1or more lines of standard therapy.
  2. * 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).
  3. * 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).
  4. * The participant's current disease state must be R/R to standard therapy.
  5. * Participants must have measurable PET positive disease in both cHL and NHL cohorts.
  1. * 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.
  2. * 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.
  3. * Prior treatment with lymphocyte activation gene-3 (LAG-3)-targeted agents.
  4. * 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.
  5. * Participants with autoimmune disease.
  6. * Prior allogeneic bone marrow transplantation.

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology
Phoenix, Arizona, 85016
United States
Lucile Packard Childrens Hospital - Stanford University
Palo Alto, California, 94304
United States
Yale University
New Haven, Connecticut, 06510
United States
Local Institution - 0061
Wilmington, Delaware, 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
AdventHealth
Orlando, Florida, 32804
United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407
United States
The Johns Hopkins Hospital JHH
Baltimore, Maryland, 21287
United States
University of Minnesota Medical School - Masonic Childrens Hospital
Minneapolis, Minnesota, 55454
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Local Institution - 0012
Saint Louis, Missouri, 63110
United States
Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute
Hackensack, New Jersey, 07601
United States
Local Institution - 0016
Bronx, New York, 10467
United States
Columbia University Medical Center
New York, New York, 10032
United States
New York Medical College
Valhalla, New York, 10595
United States
Local Institution - 0019
Hershey, Pennsylvania, 17033
United States
Local Institution - 0014
Nashville, Tennessee, 37232
United States
Dell Children's Medical Center of Central Texas (DCMC) - Strictly Pediatrics Subspecialty Center
Austin, Texas, 78723
United States
CHRISTUS Childrens
San Antonio, Texas, 78207
United States
UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-13
Study Completion Date2028-07-05

Study Record Updates

Study Start Date2022-09-13
Study Completion Date2028-07-05

Terms related to this study

Keywords Provided by Researchers

  • Pediatric
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Relatlimab
  • Nivolumab
  • Lymphocyte Activation Gene-3
  • Lymphoma, Large B-Cell, Diffuse
  • Primary Mediastinal B-cell Lymphoma
  • Lymphoma, Large-Cell, Anaplastic
  • Burkitt lymphoma
  • Lymphoblastic lymphoma
  • NK/ T-cell lymphoma
  • Peripheral T-cell lymphoma

Additional Relevant MeSH Terms

  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease