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

Lymphoma, Non-Hodgkin Clinical Trial

— RELATIVITY-069  

Official title:

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255601
• Other study ID #: CA224-069
• Secondary ID: 2021-000493-29U1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 13, 2022
• Est. completion date: July 5, 2028

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: July 5, 2028
• Est. primary completion date: July 5, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

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 a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
• Participants with pathologically confirmed R/R NHL after failure or non-response to second 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).
• Participants must have measurable PET positive disease in both cHL and NHL cohorts.

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 (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. Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Relatlimab
Specified Dose on Specified Days
• Nivolumab
Specified Dose on Specified Days

Locations

Country	Name	City	State
Australia	Local Institution - 0042	Nedlands	Western Australia
Australia	Local Institution - 0037	Randwick	New South Wales
Australia	Local Institution - 0039	South Brisbane	Queensland
France	Local Institution - 0063	Angers	Angers Cedex 9
France	Local Institution - 0048	Bordeaux
France	Local Institution - 0033	Caen
France	CHU Grenoble Alpes - Hopital Couple Enfant (HCE)	La Tronche
France	Local Institution - 0021	Lyon
France	Local Institution - 0034	Marseille
France	Local Institution - 0018	Montpellier
France	Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre	Paris
France	Local Institution - 0006	Paris
France	Local Institution - 0022	Rennes
France	CHRU de Strasbourg-Hopital de Hautepierre	Strasbourg
Germany	Local Institution - 0056	Aachen
Germany	Local Institution - 0015	Berlin
Germany	Local Institution - 0028	Giessen
Germany	Local Institution - 0036	Hamburg
Germany	Local Institution - 0008	Muenster
Germany	Local Institution - 0051	Munich
Italy	Local Institution - 0010	Aviano
Italy	Local Institution - 0007	Bologna
Italy	Local Institution - 0040	Florence
Italy	Local Institution - 0005	Genoa
Italy	Local Institution - 0070	Milan
Italy	Local Institution - 0001	Milano
Italy	Local Institution - 0043	Monza
Italy	Local Institution - 0013	Napoli
Italy	Local Institution - 0065	Padova
Italy	Local Institution - 0041	Pavia	PV
Italy	Osp. Pediatrico Bambino Gesu, IRCCS	Roma
Italy	Local Institution - 0004	Turin
Netherlands	Princess Maxima Center for pediatric oncology	Utrecht
Spain	Local Institution - 0009	Barcelona
Spain	Local Institution - 0046	Barcelona
Spain	Hospital Sant Juan de Deu Barcelona	Esplugues de Llobregat
Spain	Local Institution - 0030	Madrid
Spain	Local Institution - 0044	Madrid
Spain	Local Institution - 0045	Madrid
Spain	Local Institution - 0055	Madrid
Spain	Local Institution - 0058	Madrid
Spain	Local Institution - 0062	Pamplona	Navarra
Spain	Local Institution - 0011	Santander
Spain	Local Institution - 0023	Sevilla
Spain	Local Institution - 0038	Sevilla
Spain	Local Institution - 0049	Valencia
United Kingdom	Local Institution - 0031	Birmingham	West Midlands
United Kingdom	Local Institution - 0050	Bristol	Somerset
United Kingdom	Local Institution - 0074	Liverpool	England
United Kingdom	Local Institution - 0054	London	Londonderry
United Kingdom	Local Institution - 0068	Newcastle upon Tyne
United Kingdom	Local Institution - 0003	Nottingham	Nottinghamshire
United Kingdom	Local Institution - 0053	Sutton	Surrey
United States	Dell Children's Medical Center of Central Texas (DCMC) - Strictly Pediatrics Subspecialty Center	Austin	Texas
United States	The Johns Hopkins Hospital JHH	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute	Hackensack	New Jersey
United States	Penn State Health Milton S. Hershey Medical Center - Penn State Children's Hospital	Hershey	Pennsylvania
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic	Madison	Wisconsin
United States	University of Minnesota Medical School - Masonic Childrens Hospital	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	AdventHealth	Orlando	Florida
United States	Lucile Packard Childrens Hospital - Stanford University	Palo Alto	California
United States	Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology	Phoenix	Arizona
United States	Siteman Cancer Center - Washington University Medical Campus Location	Saint Louis	Missouri
United States	CHRISTUS Childrens	San Antonio	Texas
United States	New York Medical College	Valhalla	New York
United States	St. Mary's Medical Center	West Palm Beach	Florida
United States	Nemours Childrens Hospital	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs)		Up to 135 days following last dose
Primary	Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)		Up to 135 days following last dose
Primary	Number of participants with Adverse Events (AEs)		Up to 135 days following last dose
Primary	Number of participants with serious adverse events (SAEs)		Up to 135 days following last dose
Primary	Number of participants with AEs leading to discontinuation		Up to 135 days following last dose
Primary	Number of deaths		Up to 135 days following last dose
Primary	Number of participants with clinical laboratory abnormalities		Up to 135 days following last dose
Primary	Maximum observed plasma concentration (Cmax)		Up to 96 weeks
Primary	Trough observed concentration (Ctrough)		Up to 96 weeks
Primary	Time of maximum observed plasma concentration (Tmax)		Up to 96 weeks
Primary	Area Under the Curve within a dosing interval (AUC(TAU))		Up to 96 weeks
Primary	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
Secondary	Number of participants with AEs		Up to 135 days following last dose
Secondary	Number of participants with SAEs		Up to 135 days following last dose
Secondary	Number of participants with AEs leading to discontinuation		Up to 135 days following last dose
Secondary	Number of deaths		Up to 135 days following last dose
Secondary	Number of participants with clinical laboratory abnormalities		Up to 135 days following last dose
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting