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

study description
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.

Condition or Disease: Lymphoma, Non-Hodgkin
Hodgkin Disease
Intervention/treatment: Drug: Relatlimab
Drug: Nivolumab
Phase: Phase 1/Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 68 participants
Allocation : Non-Randomized
Intervention Model : Sequential Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date: June 2022
Estimated Primary Completion Date: July 2027
Estimated Study Completion Date: April 2030

Arms and interventions
Arm Intervention/treatment
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 ]
2. Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) [ Time Frame: Up to 100 days following last dose ]
3. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 100 days following last dose ]
4. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 100 days following last dose ]
5. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose ]
6. Number of deaths [ Time Frame: Up to 100 days following last dose ]
7. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 days following last dose ]
8. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 96 weeks ]
9. Trough observed concentration (Ctrough) [ Time Frame: Up to 96 weeks ]
10. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 96 weeks ]
11. Area Under the Curve within a dosing interval (AUC(TAU)) [ Time Frame: Up to 96 weeks ]
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 ]
Secondary Outcome Measures: 1. Number of participants with AEs [ Time Frame: Up to 100 days following last dose ]
2. Number of participants with SAEs [ Time Frame: Up to 100 days following last dose ]
3. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose ]
4. Number of deaths [ Time Frame: Up to 100 days following last dose ]
5. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 days following last dose ]
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 ]

Eligibility Criteria
Ages Eligible for Study: up to 30 / (18 to 64 years)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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


Contacts and Locations
Contacts

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
Additional relevant MeSH terms :
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases