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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05255601
Registration number
NCT05255601
Ethics application status
Date submitted
15/02/2022
Date registered
24/02/2022
Date last updated
29/05/2024
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
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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
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Secondary ID [1]
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2021-000493-29
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Secondary ID [2]
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CA224-069
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Universal Trial Number (UTN)
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Trial acronym
RELATIVITY-069
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin
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Hodgkin Disease
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Hodgkin's
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Intervention/exposure
Study type
Interventional(has expanded access)
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of dose-limiting toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Up to 135 days following last dose
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Primary outcome [2]
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Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)
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Assessment method [2]
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Timepoint [2]
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Up to 135 days following last dose
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Primary outcome [3]
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Number of participants with Adverse Events (AEs)
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Assessment method [3]
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Timepoint [3]
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Up to 135 days following last dose
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Primary outcome [4]
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Number of participants with serious adverse events (SAEs)
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Assessment method [4]
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Timepoint [4]
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Up to 135 days following last dose
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Primary outcome [5]
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Number of participants with AEs leading to discontinuation
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Assessment method [5]
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Timepoint [5]
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Up to 135 days following last dose
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Primary outcome [6]
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Number of deaths
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Assessment method [6]
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Timepoint [6]
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Up to 135 days following last dose
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Primary outcome [7]
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Number of participants with clinical laboratory abnormalities
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Assessment method [7]
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Timepoint [7]
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Up to 135 days following last dose
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Primary outcome [8]
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Maximum observed plasma concentration (Cmax)
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Assessment method [8]
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Timepoint [8]
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Up to 96 weeks
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Primary outcome [9]
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Trough observed concentration (Ctrough)
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Assessment method [9]
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Timepoint [9]
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Up to 96 weeks
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Primary outcome [10]
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Time of maximum observed plasma concentration (Tmax)
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Assessment method [10]
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Timepoint [10]
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Up to 96 weeks
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Primary outcome [11]
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Area Under the Curve within a dosing interval (AUC(TAU))
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Assessment method [11]
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Timepoint [11]
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Up to 96 weeks
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Primary outcome [12]
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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
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Assessment method [12]
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Timepoint [12]
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Up to 2 years from the last treatment of last participant
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Secondary outcome [1]
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Number of participants with AEs
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Assessment method [1]
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Timepoint [1]
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Up to 135 days following last dose
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Secondary outcome [2]
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Number of participants with SAEs
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Assessment method [2]
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Timepoint [2]
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Up to 135 days following last dose
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Secondary outcome [3]
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Number of participants with AEs leading to discontinuation
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Assessment method [3]
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Timepoint [3]
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Up to 135 days following last dose
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Secondary outcome [4]
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Number of deaths
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Assessment method [4]
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Timepoint [4]
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Up to 135 days following last dose
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Secondary outcome [5]
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Number of participants with clinical laboratory abnormalities
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Assessment method [5]
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Timepoint [5]
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Up to 135 days following last dose
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Secondary outcome [6]
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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
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Assessment method [6]
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Timepoint [6]
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Up to 2 years from the last treatment of last participant
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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.
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Minimum age
No limit
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/07/2028
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Actual
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Sample size
Target
68
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Local Institution - 0037 - Randwick
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Recruitment hospital [2]
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Local Institution - 0039 - South Brisbane
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Recruitment hospital [3]
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Local Institution - 0042 - Nedlands
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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Delaware
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Florida
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United States of America
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Maryland
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Minnesota
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Mississippi
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Missouri
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New York
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Texas
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Wisconsin
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France
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Angers Cedex 9
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France
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Bordeaux
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Caen
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France
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La Tronche
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Cambridge
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05255601
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05255601
Download to PDF