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

Phase 1

Recruiting

• Conditions: Hodgkin Disease; Lymphoma, Non-Hodgkin
• Interventions: Drug: Relatlimab; Drug: Nivolumab

• Registration Number: NCT05255601
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Study Start: 2022-09-13
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-01
• Primary Completion: 2028-07-05
• Study Completion: 2028-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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, 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.
• 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.
• Prior allogeneic bone marrow transplantation.

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Relatlimab + Nivolumab	Nivolumab	-
Relatlimab + Nivolumab	Relatlimab	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities (DLTs)	Up to 135 days following last dose	DLT evaluation window is 4 weeks from start of treatment. Safety evaluation will continue up to 135 days following last dose.
Number of participants with Adverse Events (AEs)	Up to 135 days following last dose
Number of participants with serious adverse events (SAEs)	Up to 135 days following last dose
Number of participants with AEs leading to discontinuation	Up to 135 days following last dose
Number of deaths	Up to 2 years from the last treatment of last participant
Number of participants with clinical laboratory abnormalities	Up to 135 days following last dose
Maximum observed plasma concentration (Cmax)	Up to 96 weeks
Trough observed concentration (Ctrough)	Up to 96 weeks
Time of maximum observed plasma concentration (Tmax)	Up to 96 weeks
Area Under the Curve within a dosing interval (AUC(TAU))	Up to 96 weeks
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	Up to 2 years from the last treatment of last participant
Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)	Up to 135 days following last dose

Secondary Outcome Measures

Name	Time	Method
Number of participants with AEs	Up to 135 days following last dose
Number of participants with SAEs	Up to 135 days following last dose
Number of participants with AEs leading to discontinuation	Up to 135 days following last dose
Number of deaths	Up to 2 years from the last treatment of last participant
Number of participants with clinical laboratory abnormalities	Up to 135 days following last dose
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	Up to 2 years from the last treatment of last participant

Trial Locations

Locations (75)

Local Institution - 0077; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0024; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0035; 🇺🇸 Palo Alto, California, United States

Local Institution - 0032; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0061; 🇺🇸 Wilmington, Delaware, United States

Local Institution - 0066; 🇺🇸 Fort Myers, Florida, United States

Local Institution - 0017; 🇺🇸 Orlando, Florida, United States

St. Mary's Medical Center; 🇺🇸 West Palm Beach, Florida, United States

Local Institution - 0073; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0025; 🇺🇸 Minneapolis, Minnesota, United States

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