Clinical trial NCT05255601: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lymphoma, Non-Hodgkin
Hodgkin Disease
Keywords: 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
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 68
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: Up to 135 days following last dose
measure: Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)
timeFrame: Up to 135 days following last dose
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 135 days following last dose
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 135 days following last dose
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 135 days following last dose
measure: Number of deaths
timeFrame: Up to 2 years from the last treatment of last participant
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 135 days following last dose
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 96 weeks
measure: Trough observed concentration (Ctrough)
timeFrame: Up to 96 weeks
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 96 weeks
measure: Area Under the Curve within a dosing interval (AUC(TAU))
timeFrame: Up to 96 weeks
measure: 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
timeFrame: Up to 2 years from the last treatment of last participant
Secondary outcomes:
measure: Number of participants with AEs
timeFrame: Up to 135 days following last dose
measure: Number of participants with SAEs
timeFrame: Up to 135 days following last dose
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 135 days following last dose
measure: Number of deaths
timeFrame: Up to 2 years from the last treatment of last participant
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 135 days following last dose
measure: 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
timeFrame: Up to 2 years from the last treatment of last participant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0077
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology
state: Arizona
city: Palo Alto
country: United States
facility: Lucile Packard Childrens Hospital - Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Wilmington
country: United States
facility: Local Institution - 0061
state: Delaware
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0017
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital JHH
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota Medical School - Masonic Childrens Hospital
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Local Institution - 0012
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 0016
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Hershey
country: United States
facility: Local Institution - 0019
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0014
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0029
state: Texas
city: San Antonio
country: United States
facility: CHRISTUS Childrens
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 0076
state: Virginia
city: Madison
country: United States
facility: UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic
state: Wisconsin
city: Randwick
country: Australia
facility: University of New South Wales UNSW - Sydney Childrens Hospital SCH - The Centre for Cancer and Blood Disorders
state: New South Wales
city: South Brisbane
country: Australia
facility: Royal Childrens Hospital RCH - Queensland Childrens Hospital
state: Queensland
city: Nedlands
country: Australia
facility: Perth Childrens Hospital
state: Western Australia
city: Angers
country: France
facility: CHU dAngers - Pole Pediatrie
state: Angers Cedex 9
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - Hopital des enfants
city: Caen
country: France
facility: Local Institution - 0033
city: La Tronche
country: France
facility: CHU Grenoble Alpes - Hopital Couple Enfant (HCE)
city: Lyon
country: France
facility: Institut d Hematologie et d Oncologie Pediatriques
city: Marseille
country: France
facility: Local Institution - 0034
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve
city: Paris
country: France
facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau
city: Paris
country: France
facility: Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre
city: Rennes
country: France
facility: Local Institution - 0022
city: Strasbourg
country: France
facility: CHRU de Strasbourg-Hopital de Hautepierre
city: Aachen
country: Germany
facility: Local Institution - 0056
city: Berlin
country: Germany
facility: Local Institution - 0015
city: Giessen
country: Germany
facility: Local Institution - 0028
city: Hamburg
country: Germany
facility: Local Institution - 0036
city: Muenster
country: Germany
facility: Local Institution - 0008
city: Munich
country: Germany
facility: Local Institution - 0051
city: Aviano
country: Italy
facility: Local Institution - 0010
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
city: Genoa
country: Italy
facility: Local Institution - 0005
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Dei Tumori
city: Milan
country: Italy
facility: Local Institution - 0070
city: Monza
country: Italy
facility: Fondazione MBBM - Clinica Pediatrica
city: Napoli
country: Italy
facility: Local Institution - 0013
city: Padova
country: Italy
facility: Azienda Ospedale Universita Padova
city: Pavia
country: Italy
facility: Local Institution - 0041
city: Roma
country: Italy
facility: Osp. Pediatrico Bambino Gesu; IRCCS
city: Turin
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino Ospedale Infantile Regina Margherita
city: Utrecht
country: Netherlands
facility: Princess Maxima Center for pediatric oncology
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Juan de Deu Barcelona
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall dHebron
city: Barcelona
country: Spain
facility: Local Institution - 0009
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Local Institution - 0044
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santander
country: Spain
facility: Local Institution - 0011
city: Sevilla
country: Spain
facility: Local Institution - 0038
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio HUVR
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: UCLH
state: Londonderry
city: Nottingham
country: United Kingdom
facility: Local Institution - 0003
state: Nottinghamshire
city: Bristol
country: United Kingdom
facility: Local Institution - 0050
state: Somerset
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Local Institution - 0031
state: West Midlands
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: