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| 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 |
| Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
| NCT05255601 | Not yet recruiting | February 24, 2022 | May 3, 2022 |
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| study description |
| Brief Summary |
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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. |
| Condition or Disease: |
Lymphoma, Non-Hodgkin Hodgkin Disease |
| Intervention/treatment: |
Drug: Relatlimab Drug: Nivolumab |
| Phase: | Phase 1/Phase 2 |
| Detailed Description |
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N/A |
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| study design | ||||||||||||||||||||||
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| Arms and interventions |
| Arm | Intervention/treatment |
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Experimental: Relatlimab + Nivolumab |
Drug: Relatlimab Specified Dose on Specified Days Drug: Nivolumab Specified Dose on Specified Days |
| outcome measures |
| Primary Outcome Measures: |
1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 100 days following last dose ] |
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2. Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) [ Time Frame: Up to 100 days following last dose ] |
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3. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 100 days following last dose ] |
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4. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 100 days following last dose ] |
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5. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose ] |
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6. Number of deaths [ Time Frame: Up to 100 days following last dose ] |
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7. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 days following last dose ] |
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8. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 96 weeks ] |
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9. Trough observed concentration (Ctrough) [ Time Frame: Up to 96 weeks ] |
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10. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 96 weeks ] |
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11. Area Under the Curve within a dosing interval (AUC(TAU)) [ Time Frame: Up to 96 weeks ] |
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12. 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 [ Time Frame: Up to 32 weeks following first dose ] |
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| Secondary Outcome Measures: |
1. Number of participants with AEs [ Time Frame: Up to 100 days following last dose ] |
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2. Number of participants with SAEs [ Time Frame: Up to 100 days following last dose ] |
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3. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose ] |
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4. Number of deaths [ Time Frame: Up to 100 days following last dose ] |
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5. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 days following last dose ] |
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6. 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 [ Time Frame: Up to 32 weeks following first dose ] |
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| Eligibility Criteria |
| Ages Eligible for Study: | up to 30 / (18 to 64 years) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Criteria |
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Inclusion Criteria: Pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT) Pathologically confirmed high-risk, R/R non-Hodgkin lymphoma (NHL) after failure or non-response to first-line therapy, including but not limited to diffuse large B-cell lymphoma (DLBCL), anaplastic large cell lymphoma (ALCL) and primary mediastinal B-cell lymphoma Pathologically confirmed recurrent cHL or NHL Must have measurable [18F]fluorodeoxyglucose-positron emission tomography-computed tomography (FDG-PET-CT) positive disease in both cHL and NHL cohorts Exclusion Criteria: 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 Prior autologous stem cell transplantation (HDCT/ASCT) History of allogeneic bone marrow transplantation and with active graft versus host disease (GVHD) and prior history of Grade > 2 GVHD Other protocol-defined inclusion/exclusion criteria apply |
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| Contacts and Locations |
| Contacts |
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com Contact: First line of the email MUST contain NCT # and Site #. |
| Locations |
| United States, Arizona | Local Institution | Phoenix |
| United States, Florida | Local Institution | Orlando |
| United States, Florida | Local Institution | West Palm Beach |
| United States, Minnesota | Local Institution | Minneapolis |
| United States, Mississippi | Local Institution | Jackson |
| United States, Missouri | Local Institution | Saint Louis |
| United States, New York | Local Institution | Bronx |
| United States, New York | Local Institution | Valhalla |
| United States, Pennsylvania | Local Institution | Hershey |
| United States, Tennessee | Local Institution | Nashville |
| United States, Texas | Local Institution | Austin |
| United States, Texas | Local Institution | San Antonio |
| Australia, Western Australia | Local Institution | Nedlands |
| France | Local Institution | Bordeaux |
| France | Local Institution | Lyon |
| France | Local Institution | Montpellier |
| France | Local Institution | Paris |
| France | Local Institution | Paris |
| France | Local Institution - 0022 | Rennes |
| France | Local Institution | Strasbourg |
| Germany | Local Institution | Aachen |
| Germany | Local Institution | Berlin |
| Germany | Local Institution | Giessen |
| Germany | Local Institution | Muenster |
| Germany | Local Institution | Munich |
| Italy | Local Institution | Aviano |
| Italy | Local Institution | Bologna |
| Italy | Local Institution | Florence |
| Italy | Local Institution | Genoa |
| Italy | Local Institution | Milano |
| Italy | Local Institution | Monza |
| Italy | Local Institution | Napoli |
| Italy | Local Institution | Pavia |
| Italy | Local Institution | Roma |
| Italy | Local Institution | Turin |
| Netherlands | Local Institution | Utrecht |
| Spain | Local Institution | Barcelona |
| Spain | Local Institution | Barcelona |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Santander |
| Spain | Local Institution | Sevilla |
| Spain | Local Institution | Valencia |
| United Kingdom | Local Institution | Birmingham |
| United Kingdom | Local Institution | Bristol |
| United Kingdom | Local Institution | London |
| United Kingdom | Local Institution | Nottingham |
| United Kingdom | Local Institution | Sutton |
| Sponsors and Collaborators |
| Bristol-Myers Squibb |
| Investigator | ||
| Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
| More Information | ||||||||||||
| Responsible Party : | Bristol-Myers Squibb | |||||||||||
| ClinicalTrials.gov Identifier : | NCT05255601 | |||||||||||
| Other Study ID Numbers : | CA224-069, 2021-000493-29, U1111-1264-4062 | |||||||||||
| First Posted : | February 24, 2022 | |||||||||||
| Last Update Posted : | May 3, 2022 | |||||||||||
| Last Verified : | April 2022 | |||||||||||
| Studies a U.S. FDA-regulated Drug Product: | Yes | |||||||||||
| Studies a U.S. FDA-regulated Device Product: | No | |||||||||||
| Keywords provided by Bristol-Myers Squibb: |
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 |
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| Additional relevant MeSH terms : |
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