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

Phase 1

• Conditions: Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma; MedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: HLGTClassification code 10025322Term: Lymphomas non-Hodgkin's unspecified histologySystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000493-29-NL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-14
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• 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 first-line standard therapy prior to definitive treatment (eg, HDCT/ASCT).

• Participants with pathologically confirmed R/R NHL after failure or non-response to first-line therapy, including but not limited to 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 57
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia.

• 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 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 LAG-3-targeted agents.

• Participants with prior autologous stem cell transplantation (HDCT/ASCT).

• 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.

• Participants who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified