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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 (RELATIVITY-069)

  • Clinicaltrials.gov identifier

    NCT05255601

  • Recruitment Status

    Not yet recruiting

  • First Posted

    February 24, 2022

  • Last update posted

    May 3, 2022

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Study Description

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: Drug: Relatlimab
    Drug: Nivolumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 68 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Estimated Study Start Date: June 2022
  • Estimated Primary Completion Date: July 2027
  • Estimated Study Completion Date: April 2030

Arms and interventions

Arm Intervention/treatment
Experimental: Relatlimab + Nivolumab
 Drug: Relatlimab
Specified Dose on Specified Days

Drug: Nivolumab
Specified Dose on Specified Days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 100 days following last dose ]
  • 2. Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) [ Time Frame: Up to 100 days following last dose ]
  • 3. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 100 days following last dose ]
  • 4. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 100 days following last dose ]
  • 5. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose ]
  • 6. Number of deaths [ Time Frame: Up to 100 days following last dose ]
  • 7. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 days following last dose ]
  • 8. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 96 weeks ]
  • 9. Trough observed concentration (Ctrough) [ Time Frame: Up to 96 weeks ]
  • 10. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 96 weeks ]
  • 11. Area Under the Curve within a dosing interval (AUC(TAU)) [ Time Frame: Up to 96 weeks ]
  • 12. Complete Metabolic Response (CMR) Rate defined as the proportion of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria [ Time Frame: Up to 32 weeks following first dose ]
  • Secondary Outcome Measures: 1. Number of participants with AEs [ Time Frame: Up to 100 days following last dose ]
  • 2. Number of participants with SAEs [ Time Frame: Up to 100 days following last dose ]
  • 3. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose ]
  • 4. Number of deaths [ Time Frame: Up to 100 days following last dose ]
  • 5. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 days following last dose ]
  • 6. Overall Response Rate (ORR) defined as the proportion of all response- evaluable participants who achieve a best response of CMR or partial metabolic response (PMR) using the Lugano 2014 classification [ Time Frame: Up to 32 weeks following first dose ]

Eligibility Criteria

  • Ages Eligible for Study: up to 30 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT) Pathologically confirmed high-risk, R/R non-Hodgkin lymphoma (NHL) after failure or non-response to first-line therapy, including but not limited to diffuse large B-cell lymphoma (DLBCL), anaplastic large cell lymphoma (ALCL) and primary mediastinal B-cell lymphoma Pathologically confirmed recurrent cHL or NHL Must have measurable [18F]fluorodeoxyglucose-positron emission tomography-computed tomography (FDG-PET-CT) positive disease in both cHL and NHL cohorts Exclusion Criteria: 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 Prior autologous stem cell transplantation (HDCT/ASCT) History of allogeneic bone marrow transplantation and with active graft versus host disease (GVHD) and prior history of Grade > 2 GVHD Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arizona
Local Institution
Phoenix

United States, Florida
Local Institution
Orlando

United States, Florida
Local Institution
West Palm Beach

United States, Minnesota
Local Institution
Minneapolis

United States, Mississippi
Local Institution
Jackson

United States, Missouri
Local Institution
Saint Louis

United States, New York
Local Institution
Bronx

United States, New York
Local Institution
Valhalla

United States, Pennsylvania
Local Institution
Hershey

United States, Tennessee
Local Institution
Nashville

United States, Texas
Local Institution
Austin

United States, Texas
Local Institution
San Antonio

Australia, Western Australia
Local Institution
Nedlands

France
Local Institution
Bordeaux

France
Local Institution
Lyon

France
Local Institution
Montpellier

France
Local Institution
Paris

France
Local Institution
Paris

France
Local Institution - 0022
Rennes

France
Local Institution
Strasbourg

Germany
Local Institution
Aachen

Germany
Local Institution
Berlin

Germany
Local Institution
Giessen

Germany
Local Institution
Muenster

Germany
Local Institution
Munich

Italy
Local Institution
Aviano

Italy
Local Institution
Bologna

Italy
Local Institution
Florence

Italy
Local Institution
Genoa

Italy
Local Institution
Milano

Italy
Local Institution
Monza

Italy
Local Institution
Napoli

Italy
Local Institution
Pavia

Italy
Local Institution
Roma

Italy
Local Institution
Turin

Netherlands
Local Institution
Utrecht

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Santander

Spain
Local Institution
Sevilla

Spain
Local Institution
Valencia

United Kingdom
Local Institution
Birmingham

United Kingdom
Local Institution
Bristol

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Nottingham

United Kingdom
Local Institution
Sutton

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05255601 History of Changes
  • Other Study ID Numbers: CA224-069, 2021-000493-29, U1111-1264-4062
  • First Posted: February 24, 2022 Key Record Dates
  • Last Update Posted: May 3, 2022
  • Last Verified: April 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: 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
  • Additional relevant MeSH terms: Lymphoma
    Lymphoma, Non-Hodgkin
    Hodgkin Disease
    Neoplasms by Histologic Type
    Neoplasms     Lymphoproliferative Disorders
    Lymphatic Diseases
    Immunoproliferative Disorders
    Immune System Diseases