TerminatedPhase 1/2

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

United States, Australia, France5 participantsStarted 2022-09-13

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

Timeframe: 1 cycle, defined as 28 days

Complete Metabolic Response (CMR) Rate - Part B

Timeframe: From first dose until the first documented response

Number of Participants With Adverse Events (AEs) - Part A

Timeframe: From first dose to 135 days post last dose (Up to approximately 11 months)

Number of Participants Who Died - Part A

Timeframe: from first dose to 135 days post last dose (Up to approximately 11 months)

Number of Participants With Serious Adverse Events (SAEs) - Part A

Timeframe: from first dose to 135 days post last dose (Up to approximately 11 months)

Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A

Timeframe: From first dose to 135 days post last dose (Up to approximately 11 months)

Trial details

NCT IDNCT05255601

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-03

Results submitted2026-06-02

View on ClinicalTrials.gov More Lymphoma, Non-Hodgkin trials

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

Timeframe: 1 cycle, defined as 28 days

Complete Metabolic Response (CMR) Rate - Part B

Timeframe: From first dose until the first documented response

Number of Participants With Adverse Events (AEs) - Part A

Timeframe: From first dose to 135 days post last dose (Up to approximately 11 months)

Number of Participants Who Died - Part A

Timeframe: from first dose to 135 days post last dose (Up to approximately 11 months)

Number of Participants With Serious Adverse Events (SAEs) - Part A

Timeframe: from first dose to 135 days post last dose (Up to approximately 11 months)

Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A

Timeframe: From first dose to 135 days post last dose (Up to approximately 11 months)