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

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.

Conditions

Lymphoma, Non-Hodgkin, Hodgkin Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lymphoma, Non-Hodgkin
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology, Phoenix, Arizona, United States, 85016

Palo Alto

Lucile Packard Childrens Hospital - Stanford University, Palo Alto, California, United States, 94304

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Wilmington

Local Institution - 0061, Wilmington, Delaware, United States, 19803

Fort Myers

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States, 33908

Orlando

AdventHealth, Orlando, Florida, United States, 32804

West Palm Beach

St. Mary's Medical Center, West Palm Beach, Florida, United States, 33407

Baltimore

The Johns Hopkins Hospital JHH, Baltimore, Maryland, United States, 21287

Minneapolis

University of Minnesota Medical School - Masonic Childrens Hospital, Minneapolis, Minnesota, United States, 55454

Jackson

University of Mississippi Medical Center, Jackson, Mississippi, United States, 39216

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2028-07-05