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

Who is this study for? Pediatric and young adult patients with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma
What treatments are being studied? Relatlimab+Nivolumab
Status: Recruiting
Location: See all (76) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Local Institution - 0077
NOT_YET_RECRUITING
Birmingham
Arizona
Local Institution - 0024
COMPLETED
Phoenix
California
Local Institution - 0035
COMPLETED
Palo Alto
Connecticut
Local Institution - 0032
COMPLETED
New Haven
Delaware
Local Institution - 0061
WITHDRAWN
Wilmington
Florida
Local Institution - 0066
COMPLETED
Fort Myers
Local Institution - 0017
WITHDRAWN
Orlando
St. Mary's Medical Center
WITHDRAWN
West Palm Beach
Maryland
Local Institution - 0073
COMPLETED
Baltimore
Minnesota
Local Institution - 0025
COMPLETED
Minneapolis
Missouri
Local Institution - 0012
WITHDRAWN
St Louis
Mississippi
Local Institution - 0020
COMPLETED
Jackson
New Jersey
Local Institution - 0071
COMPLETED
Hackensack
New York
Local Institution - 0060
COMPLETED
New York
Local Institution - 0016
WITHDRAWN
The Bronx
Local Institution - 0059
COMPLETED
Valhalla
Pennsylvania
Local Institution - 0019
WITHDRAWN
Hershey
Tennessee
Local Institution - 0014
WITHDRAWN
Nashville
Texas
Local Institution - 0029
NOT_YET_RECRUITING
Austin
Local Institution - 0026
COMPLETED
San Antonio
Virginia
Local Institution - 0076
WITHDRAWN
Norfolk
Wisconsin
UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic
WITHDRAWN
Madison
Other Locations
Australia
Perth Childrens Hospital
RECRUITING
Nedlands
University of New South Wales UNSW - Sydney Childrens Hospital SCH - The Centre for Cancer and Blood Disorders
RECRUITING
Randwick
Royal Childrens Hospital RCH - Queensland Childrens Hospital
RECRUITING
South Brisbane
France
CHU dAngers - Pole Pediatrie
RECRUITING
Angers
Groupe Hospitalier Pellegrin - Hopital des enfants
RECRUITING
Bordeaux
Local Institution - 0033
NOT_YET_RECRUITING
Caen
CHU Grenoble Alpes - Hopital Couple Enfant (HCE)
RECRUITING
La Tronche
Institut d Hematologie et d Oncologie Pediatriques
RECRUITING
Lyon
Local Institution - 0034
WITHDRAWN
Marseille
Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve
RECRUITING
Montpellier
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau
RECRUITING
Paris
Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre
RECRUITING
Paris
Local Institution - 0022
WITHDRAWN
Rennes
CHRU de Strasbourg-Hopital de Hautepierre
RECRUITING
Strasbourg
Germany
Local Institution - 0056
WITHDRAWN
Aachen
Local Institution - 0015
WITHDRAWN
Berlin
Local Institution - 0028
WITHDRAWN
Giessen
Local Institution - 0036
WITHDRAWN
Hamburg
Local Institution - 0051
WITHDRAWN
Munich
Local Institution - 0008
WITHDRAWN
Münster
Italy
Local Institution - 0010
NOT_YET_RECRUITING
Aviano
Azienda Ospedaliero Universitaria di Bologna
RECRUITING
Bologna
Local Institution - 0040
COMPLETED
Florence
Local Institution - 0005
WITHDRAWN
Genoa
Fondazione IRCCS Istituto Nazionale Dei Tumori
RECRUITING
Milan
Local Institution - 0070
NOT_YET_RECRUITING
Milan
Fondazione MBBM - Clinica Pediatrica
RECRUITING
Monza
Local Institution - 0013
WITHDRAWN
Napoli
Azienda Ospedale Universita Padova
RECRUITING
Padua
Local Institution - 0041
NOT_YET_RECRUITING
Pavia
Osp. Pediatrico Bambino Gesu; IRCCS
RECRUITING
Roma
A.O.U. Citta della Salute e della Scienza di Torino Ospedale Infantile Regina Margherita
RECRUITING
Turin
Netherlands
Princess Maxima Center for pediatric oncology
RECRUITING
Utrecht
Spain
Hospital Universitari Vall dHebron
RECRUITING
Barcelona
Local Institution - 0009
WITHDRAWN
Barcelona
Hospital Sant Juan de Deu Barcelona
RECRUITING
Esplugues De Llobregat
Clinica Universidad de Navarra
RECRUITING
Madrid
Hospital Infantil Universitario Nino Jesus
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Local Institution - 0044
NOT_YET_RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Local Institution - 0011
WITHDRAWN
Santander
Hospital Universitario Virgen del Rocio HUVR
RECRUITING
Seville
Local Institution - 0038
WITHDRAWN
Seville
Local Institution - 0049
COMPLETED
Valencia
United Kingdom
Local Institution - 0031
WITHDRAWN
Birmingham
Local Institution - 0050
WITHDRAWN
Bristol
Local Institution - 0075
COMPLETED
Cambridge
Local Institution - 0074
COMPLETED
Liverpool
Local Institution - 0053
COMPLETED
London
Local Institution - 0054
COMPLETED
London
Local Institution - 0068
COMPLETED
Newcastle Upon Tyne
Local Institution - 0003
WITHDRAWN
Nottingham
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2028-07-05
Participants
Target number of participants: 68
Treatments
Experimental: Relatlimab + Nivolumab
Related Therapeutic Areas
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Classical Hodgkin Lymphoma
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov

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