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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05255601




Registration number
NCT05255601
Ethics application status
Date submitted
15/02/2022
Date registered
24/02/2022
Date last updated
20/08/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2021-000493-29
Secondary ID [2] 0 0
CA224-069
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-069
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin 0 0
Hodgkin Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Relatlimab
Treatment: Drugs - Nivolumab

Experimental: Relatlimab + Nivolumab -


Treatment: Drugs: Relatlimab
Specified Dose on Specified Days

Treatment: Drugs: Nivolumab
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 135 days following last dose
Primary outcome [2] 0 0
Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)
Timepoint [2] 0 0
Up to 135 days following last dose
Primary outcome [3] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [3] 0 0
Up to 135 days following last dose
Primary outcome [4] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [4] 0 0
Up to 135 days following last dose
Primary outcome [5] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [5] 0 0
Up to 135 days following last dose
Primary outcome [6] 0 0
Number of deaths
Timepoint [6] 0 0
Up to 135 days following last dose
Primary outcome [7] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [7] 0 0
Up to 135 days following last dose
Primary outcome [8] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [8] 0 0
Up to 96 weeks
Primary outcome [9] 0 0
Trough observed concentration (Ctrough)
Timepoint [9] 0 0
Up to 96 weeks
Primary outcome [10] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [10] 0 0
Up to 96 weeks
Primary outcome [11] 0 0
Area Under the Curve within a dosing interval (AUC(TAU))
Timepoint [11] 0 0
Up to 96 weeks
Primary outcome [12] 0 0
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
Timepoint [12] 0 0
Up to 2 years from the last treatment of last participant
Secondary outcome [1] 0 0
Number of participants with AEs
Timepoint [1] 0 0
Up to 135 days following last dose
Secondary outcome [2] 0 0
Number of participants with SAEs
Timepoint [2] 0 0
Up to 135 days following last dose
Secondary outcome [3] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [3] 0 0
Up to 135 days following last dose
Secondary outcome [4] 0 0
Number of deaths
Timepoint [4] 0 0
Up to 135 days following last dose
Secondary outcome [5] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [5] 0 0
Up to 135 days following last dose
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to 2 years from the last treatment of last participant

Eligibility
Key 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.
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/07/2028
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
University of New South Wales UNSW - Sydney Childrens Hospital SCH - The Centre for Cancer and Blood Disorders - Randwick
Recruitment hospital [2] 0 0
Local Institution - 0039 - South Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0042 - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
France
State/province [16] 0 0
Angers Cedex 9
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Caen
Country [19] 0 0
France
State/province [19] 0 0
La Tronche
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Montpellier
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Rennes
Country [25] 0 0
France
State/province [25] 0 0
Strasbourg
Country [26] 0 0
Germany
State/province [26] 0 0
Aachen
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Giessen
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Muenster
Country [31] 0 0
Germany
State/province [31] 0 0
Munich
Country [32] 0 0
Italy
State/province [32] 0 0
PV
Country [33] 0 0
Italy
State/province [33] 0 0
Aviano
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
State/province [35] 0 0
Florence
Country [36] 0 0
Italy
State/province [36] 0 0
Genoa
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Milan
Country [39] 0 0
Italy
State/province [39] 0 0
Monza
Country [40] 0 0
Italy
State/province [40] 0 0
Napoli
Country [41] 0 0
Italy
State/province [41] 0 0
Padova
Country [42] 0 0
Italy
State/province [42] 0 0
Roma
Country [43] 0 0
Italy
State/province [43] 0 0
Turin
Country [44] 0 0
Netherlands
State/province [44] 0 0
Utrecht
Country [45] 0 0
Spain
State/province [45] 0 0
Navarra
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Esplugues de Llobregat
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Santander
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
United Kingdom
State/province [52] 0 0
England
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Londonderry
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Nottinghamshire
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Somerset
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Surrey
Country [57] 0 0
United Kingdom
State/province [57] 0 0
West Midlands
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Cambridge
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05255601