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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05255601
Other study ID # CA224-069
Secondary ID 2021-000493-29U1
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 13, 2022
Est. completion date July 5, 2028

Study information

Verified date May 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date July 5, 2028
Est. primary completion date July 5, 2028
Accepts healthy volunteers No
Gender All
Age group N/A to 30 Years
Eligibility 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 a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT) - Participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to 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 must have measurable PET positive disease in both cHL and NHL cohorts. Exclusion Criteria: - Aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia. - 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 - Prior autologous stem cell transplantation (HDCT/ASCT) - History of allogeneic bone marrow transplantation. Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Relatlimab
Specified Dose on Specified Days
Nivolumab
Specified Dose on Specified Days

Locations

Country Name City State
Australia Local Institution - 0042 Nedlands Western Australia
Australia Local Institution - 0037 Randwick New South Wales
Australia Local Institution - 0039 South Brisbane Queensland
France Local Institution - 0063 Angers Angers Cedex 9
France Local Institution - 0048 Bordeaux
France Local Institution - 0033 Caen
France CHU Grenoble Alpes - Hopital Couple Enfant (HCE) La Tronche
France Local Institution - 0021 Lyon
France Local Institution - 0034 Marseille
France Local Institution - 0018 Montpellier
France Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre Paris
France Local Institution - 0006 Paris
France Local Institution - 0022 Rennes
France CHRU de Strasbourg-Hopital de Hautepierre Strasbourg
Germany Local Institution - 0056 Aachen
Germany Local Institution - 0015 Berlin
Germany Local Institution - 0028 Giessen
Germany Local Institution - 0036 Hamburg
Germany Local Institution - 0008 Muenster
Germany Local Institution - 0051 Munich
Italy Local Institution - 0010 Aviano
Italy Local Institution - 0007 Bologna
Italy Local Institution - 0040 Florence
Italy Local Institution - 0005 Genoa
Italy Local Institution - 0070 Milan
Italy Local Institution - 0001 Milano
Italy Local Institution - 0043 Monza
Italy Local Institution - 0013 Napoli
Italy Local Institution - 0065 Padova
Italy Local Institution - 0041 Pavia PV
Italy Osp. Pediatrico Bambino Gesu, IRCCS Roma
Italy Local Institution - 0004 Turin
Netherlands Princess Maxima Center for pediatric oncology Utrecht
Spain Local Institution - 0009 Barcelona
Spain Local Institution - 0046 Barcelona
Spain Hospital Sant Juan de Deu Barcelona Esplugues de Llobregat
Spain Local Institution - 0030 Madrid
Spain Local Institution - 0044 Madrid
Spain Local Institution - 0045 Madrid
Spain Local Institution - 0055 Madrid
Spain Local Institution - 0058 Madrid
Spain Local Institution - 0062 Pamplona Navarra
Spain Local Institution - 0011 Santander
Spain Local Institution - 0023 Sevilla
Spain Local Institution - 0038 Sevilla
Spain Local Institution - 0049 Valencia
United Kingdom Local Institution - 0031 Birmingham West Midlands
United Kingdom Local Institution - 0050 Bristol Somerset
United Kingdom Local Institution - 0075 Cambridge
United Kingdom Local Institution - 0074 Liverpool England
United Kingdom Local Institution - 0054 London Londonderry
United Kingdom Local Institution - 0068 Newcastle upon Tyne
United Kingdom Local Institution - 0003 Nottingham Nottinghamshire
United Kingdom Local Institution - 0053 Sutton Surrey
United States Dell Children's Medical Center of Central Texas (DCMC) - Strictly Pediatrics Subspecialty Center Austin Texas
United States The Johns Hopkins Hospital JHH Baltimore Maryland
United States Montefiore Medical Center Bronx New York
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute Hackensack New Jersey
United States Penn State Health Milton S. Hershey Medical Center - Penn State Children's Hospital Hershey Pennsylvania
United States University of Mississippi Medical Center Jackson Mississippi
United States UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic Madison Wisconsin
United States University of Minnesota Medical School - Masonic Childrens Hospital Minneapolis Minnesota
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States Columbia University Medical Center New York New York
United States AdventHealth Orlando Florida
United States Lucile Packard Childrens Hospital - Stanford University Palo Alto California
United States Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology Phoenix Arizona
United States Siteman Cancer Center - Washington University Medical Campus Location Saint Louis Missouri
United States CHRISTUS Childrens San Antonio Texas
United States New York Medical College Valhalla New York
United States St. Mary's Medical Center West Palm Beach Florida
United States Local Institution - 0061 Wilmington Delaware

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose-limiting toxicities (DLTs) Up to 135 days following last dose
Primary Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) Up to 135 days following last dose
Primary Number of participants with Adverse Events (AEs) Up to 135 days following last dose
Primary Number of participants with serious adverse events (SAEs) Up to 135 days following last dose
Primary Number of participants with AEs leading to discontinuation Up to 135 days following last dose
Primary Number of deaths Up to 135 days following last dose
Primary Number of participants with clinical laboratory abnormalities Up to 135 days following last dose
Primary Maximum observed plasma concentration (Cmax) Up to 96 weeks
Primary Trough observed concentration (Ctrough) Up to 96 weeks
Primary Time of maximum observed plasma concentration (Tmax) Up to 96 weeks
Primary Area Under the Curve within a dosing interval (AUC(TAU)) Up to 96 weeks
Primary 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 Up to 2 years from the last treatment of last participant
Secondary Number of participants with AEs Up to 135 days following last dose
Secondary Number of participants with SAEs Up to 135 days following last dose
Secondary Number of participants with AEs leading to discontinuation Up to 135 days following last dose
Secondary Number of deaths Up to 135 days following last dose
Secondary Number of participants with clinical laboratory abnormalities Up to 135 days following last dose
Secondary 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 Up to 2 years from the last treatment of last participant
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