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2023-503715-14-00CompletedPhase 1/2

Relatlimab + Nivolumab in Pediatric and Young Adult Lymphomas (RELATIVITY-069)

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Dec 2025

Next steps

Brief summary (registry, in English)

Part A: To characterize the safety, tolerability, and define the MTD or RP2D for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part A: To characterize the PK of relatlimab for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part B: To assess the preliminary efficacy of relatlimab + nivolumab based on the RP2D from part A in participants less than or equal to 30 years old with cHL (Cohort 1).

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
35 (actual)
First submitted
27 Jul 2023
Start date
29 Dec 2022
Lead sponsor
Bristol Myers Squibb International Corporation
EU CT number
2023-503715-14-00
EudraCT number
2021-000493-29

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 35
  • 30 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with LAG-3-targeted agents.

Other illness

  • Participants with a history of allogeneic bone marrow transplantation.
  • 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.

Lab values

  • Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies.

Other

  • 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.
  • Participants who are pregnant or breastfeeding.

Who the study is looking for

  • Male and female participants less than 18 years of age (Part A), and less than or equal to 30 years of age (Part B) with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Cohort 1) and Non Hodgkin Lymphoma (NHL) (Cohort 2).
  • Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1 or more lines of standard therapy.
  • Participants with pathologically confirmed R/R NHL after non-response to or failure of 1 or 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).
  • 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.
  • 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).

Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (30)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'HebronBarcelonaSpainCompleted
Sant Joan De Deu Barcelona HospitalEsplugues De LlobregatSpainCompleted
Hospital Infantil Universitario Nino JesusMadridSpainCompleted
Clinica Universidad de NavarraMadridSpainCompleted
Hospital Universitario La PazMadridSpainCompleted
Hospital Universitario Fundación Jiménez DíazMadridSpainCompleted
Hospital Universitario 12 de OctubreMadridSpainCompleted
Clínica Universidad de navarraPamplonaSpainCompleted
University Hospital Virgen Del Rocio S.L.SevillaSpainCompleted
Hospital Universitario Y Politecnico La FeValenciaSpainCompleted
Centre Hospitalier Regional D'AngersAngersFranceCompleted
Centre hospitalier Universitaire de BordeauxBordeauxFranceCompleted
Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9FranceCompleted
Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9FranceCompleted
Centre Leon BerardLyonFranceCompleted
University Hospital Of MontpellierMontpellier Cedex 5FranceCompleted
Trousseau HospitalParisFranceCompleted
Assistance Publique Hopitaux de ParisParisFranceCompleted
Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex 2FranceCompleted
Centro di Riferimento Oncologico di AvianoAvianoItalyCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBolognaItalyCompleted
Azienda Ospedaliera Universitaria Meyer IRCCSFlorenceItalyCompleted
ASST Grande Ospedale Metropolitano NiguardaMilanItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanItalyCompleted
Fondazione IRCCS San Gerardo dei TintoriMonzaItalyCompleted
Dipartimento Di Salute Della Donna E Del BambinoPadovaItalyCompleted
Fondazione IRCCS Policlinico San MatteoPaviaItalyCompleted
Bambino Gesu Childrens HospitalRomeItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurinItalyCompleted
Prinses Maxima Centrum voor Kinderoncologie B.V.UtrechtNetherlandsCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.