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
- Conditions
- Hodgkin DiseaseLymphoma, Non-Hodgkin
- Interventions
- Registration Number
- NCT05255601
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Relatlimab + Nivolumab Nivolumab - Relatlimab + Nivolumab Relatlimab -
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) Up to 135 days following last dose DLT evaluation window is 4 weeks from start of treatment. Safety evaluation will continue up to 135 days following last dose.
Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) Up to 135 days following last dose Number of participants with Adverse Events (AEs) Up to 135 days following last dose Number of participants with serious adverse events (SAEs) Up to 135 days following last dose Number of participants with AEs leading to discontinuation Up to 135 days following last dose Number of deaths Up to 2 years from the last treatment of last participant Number of participants with clinical laboratory abnormalities Up to 135 days following last dose Maximum observed plasma concentration (Cmax) Up to 96 weeks Trough observed concentration (Ctrough) Up to 96 weeks Time of maximum observed plasma concentration (Tmax) Up to 96 weeks Area Under the Curve within a dosing interval (AUC(TAU)) Up to 96 weeks 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 Outcome Measures
Name Time Method Number of participants with AEs Up to 135 days following last dose Number of participants with SAEs Up to 135 days following last dose Number of participants with AEs leading to discontinuation Up to 135 days following last dose Number of deaths Up to 2 years from the last treatment of last participant Number of participants with clinical laboratory abnormalities Up to 135 days following last dose 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
Trial Locations
- Locations (75)
Local Institution - 0013
🇮🇹Napoli, Italy
Fondazione MBBM - Clinica Pediatrica
🇮🇹Monza, Italy
Local Institution - 0017
🇺🇸Orlando, Florida, United States
Local Institution - 0029
🇺🇸Austin, Texas, United States
Royal Childrens Hospital RCH - Queensland Childrens Hospital
🇦🇺South Brisbane, Queensland, Australia
CHU dAngers - Pole Pediatrie
🇫🇷Angers, Angers Cedex 9, France
Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau
🇫🇷Paris, France
Azienda Ospedaliero Universitaria di Bologna
🇮🇹Bologna, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori
🇮🇹Milano, Italy
Osp. Pediatrico Bambino Gesu; IRCCS
🇮🇹Roma, Italy
A.O.U. Citta della Salute e della Scienza di Torino Ospedale Infantile Regina Margherita
🇮🇹Turin, Italy
The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle upon Tyne, Tyne And Wear, United Kingdom
Local Institution - 0077
🇺🇸Birmingham, Alabama, United States
Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology
🇺🇸Phoenix, Arizona, United States
Lucile Packard Childrens Hospital - Stanford University
🇺🇸Palo Alto, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Local Institution - 0061
🇺🇸Wilmington, Delaware, United States
Golisano Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
The Johns Hopkins Hospital JHH
🇺🇸Baltimore, Maryland, United States
University of Minnesota Medical School - Masonic Childrens Hospital
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Local Institution - 0012
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0016
🇺🇸Bronx, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Local Institution - 0019
🇺🇸Hershey, Pennsylvania, United States
Local Institution - 0014
🇺🇸Nashville, Tennessee, United States
CHRISTUS Childrens
🇺🇸San Antonio, Texas, United States
Local Institution - 0076
🇺🇸Norfolk, Virginia, United States
UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic
🇺🇸Madison, Wisconsin, United States
University of New South Wales UNSW - Sydney Childrens Hospital SCH - The Centre for Cancer and Blood Disorders
🇦🇺Randwick, New South Wales, Australia
Perth Childrens Hospital
🇦🇺Nedlands, Western Australia, Australia
Groupe Hospitalier Pellegrin - Hopital des enfants
🇫🇷Bordeaux, France
Local Institution - 0033
🇫🇷Caen, France
CHU Grenoble Alpes - Hopital Couple Enfant (HCE)
🇫🇷La Tronche, France
Institut d Hematologie et d Oncologie Pediatriques
🇫🇷Lyon, France
Local Institution - 0034
🇫🇷Marseille, France
Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre
🇫🇷Paris, France
Local Institution - 0022
🇫🇷Rennes, France
CHRU de Strasbourg-Hopital de Hautepierre
🇫🇷Strasbourg, France
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, Germany
Local Institution - 0010
🇮🇹Aviano, Italy
Azienda Ospedaliero Universitaria Meyer
🇮🇹Florence, Italy
Local Institution - 0005
🇮🇹Genoa, Italy
Local Institution - 0070
🇮🇹Milan, Italy
Azienda Ospedale Universita Padova
🇮🇹Padova, Italy
Local Institution - 0041
🇮🇹Pavia, Italy
Princess Maxima Center for pediatric oncology
🇳🇱Utrecht, Netherlands
Hospital Sant Juan de Deu Barcelona
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra
🇪🇸Madrid, Spain
Hospital Universitari Vall dHebron
🇪🇸Barcelona, Spain
Local Institution - 0009
🇪🇸Barcelona, Spain
Hospital Infantil Universitario Nino Jesus
🇪🇸Madrid, Spain
Local Institution - 0044
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Local Institution - 0011
🇪🇸Santander, Spain
Local Institution - 0038
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio HUVR
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Alder Hey Children's NHS Foundation Trust
🇬🇧Liverpool, England, United Kingdom
UCLH
🇬🇧London, Londonderry, United Kingdom
Local Institution - 0003
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0050
🇬🇧Bristol, Somerset, United Kingdom
Local Institution - 0031
🇬🇧Birmingham, West Midlands, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
🇬🇧London, United Kingdom