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
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
- Diseases
- Childhood cancers, Hodgkin lymphoma
- 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
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Sant Joan De Deu Barcelona Hospital | Esplugues De Llobregat | Spain | Completed |
| Hospital Infantil Universitario Nino Jesus | Madrid | Spain | Completed |
| Clinica Universidad de Navarra | Madrid | Spain | Completed |
| Hospital Universitario La Paz | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Clínica Universidad de navarra | Pamplona | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Centre Hospitalier Regional D'Angers | Angers | France | Completed |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Completed |
| Centre Hospitalier Universitaire De Caen Normandie | Caen Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Completed |
| Centre Leon Berard | Lyon | France | Completed |
| University Hospital Of Montpellier | Montpellier Cedex 5 | France | Completed |
| Trousseau Hospital | Paris | France | Completed |
| Assistance Publique Hopitaux de Paris | Paris | France | Completed |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex 2 | France | Completed |
| Centro di Riferimento Oncologico di Aviano | Aviano | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Completed |
| Azienda Ospedaliera Universitaria Meyer IRCCS | Florence | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Completed |
| Dipartimento Di Salute Della Donna E Del Bambino | Padova | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Completed |
| Bambino Gesu Childrens Hospital | Rome | Italy | Completed |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Completed |
| Prinses Maxima Centrum voor Kinderoncologie B.V. | Utrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.