Clincosm LogoSign in Get a demo

RELATIVITY-069: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05255601
Collaborator
(none)
68
Enrollment
54
Locations
1
Arm
56.9
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 31, 2027
Anticipated Study Completion Date :
May 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Relatlimab + Nivolumab

Drug: Relatlimab
Specified Dose on Specified Days
Other Names:
  • BMS-986016

    • Drug: Nivolumab
    Specified Dose on Specified Days
    Other Names:
  • BMS-936558

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities (DLTs) [Up to 100 days following last dose]

    2. Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) [Up to 100 days following last dose]

    3. Number of participants with Adverse Events (AEs) [Up to 100 days following last dose]

    4. Number of participants with serious adverse events (SAEs) [Up to 100 days following last dose]

    5. Number of participants with AEs leading to discontinuation [Up to 100 days following last dose]

    6. Number of deaths [Up to 100 days following last dose]

    7. Number of participants with clinical laboratory abnormalities [Up to 100 days following last dose]

    8. Maximum observed plasma concentration (Cmax) [Up to 96 weeks]

    9. Trough observed concentration (Ctrough) [Up to 96 weeks]

    10. Time of maximum observed plasma concentration (Tmax) [Up to 96 weeks]

    11. Area Under the Curve within a dosing interval (AUC(TAU)) [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 [Up to 32 weeks following first dose]

    Secondary Outcome Measures

    1. Number of participants with AEs [Up to 100 days following last dose]

    2. Number of participants with SAEs [Up to 100 days following last dose]

    3. Number of participants with AEs leading to discontinuation [Up to 100 days following last dose]

    4. Number of deaths [Up to 100 days following last dose]

    5. Number of participants with clinical laboratory abnormalities [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 [Up to 32 weeks following first dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Local Institution Phoenix Arizona United States 85016
    2 $Form.Name Wilmington Delaware United States 19803
    3 Local Institution Orlando Florida United States 32804
    4 Local Institution West Palm Beach Florida United States 33407
    5 Local Institution Minneapolis Minnesota United States 55454
    6 Local Institution Jackson Mississippi United States 39216
    7 Local Institution Saint Louis Missouri United States 63110
    8 Local Institution Bronx New York United States 10467
    9 $Form.Name New York New York United States 10032
    10 Local Institution Valhalla New York United States 10595
    11 Local Institution Hershey Pennsylvania United States 17033
    12 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    13 Local Institution Austin Texas United States 78723
    14 Local Institution San Antonio Texas United States 78207
    15 Local Institution - 0037 Randwick New South Wales Australia 2031
    16 Local Institution Nedlands Western Australia Australia 6009
    17 Local Institution Bordeaux France 33076
    18 Local Institution Lyon France 69373 Cedex 08
    19 Local Institution Montpellier France 34295
    20 Local Institution Paris France 75019
    21 Local Institution - 0006 Paris France 75571
    22 Local Institution - 0022 Rennes France 35203
    23 Local Institution Strasbourg France 67098
    24 Local Institution Aachen Germany 52074
    25 Local Institution Berlin Germany 13353
    26 Local Institution Giessen Germany 35392
    27 Local Institution Muenster Germany 48149
    28 Local Institution Munich Germany 80337
    29 Local Institution Aviano Italy 33081
    30 Local Institution Bologna Italy 40138
    31 Local Institution Florence Italy 50139
    32 Local Institution Genoa Italy 16147
    33 Local Institution Milano Italy
    34 Local Institution Monza Italy 20900
    35 Local Institution Napoli Italy 80131
    36 Local Institution Pavia Italy 27100
    37 Local Institution Roma Italy 165
    38 Local Institution Turin Italy 10126
    39 Local Institution Utrecht Netherlands 3584 CS
    40 Local Institution Barcelona Spain 8026
    41 Local Institution Barcelona Spain 8035
    42 Local Institution Madrid Spain 28009
    43 Local Institution Madrid Spain 28027
    44 Local Institution Madrid Spain 28040
    45 Local Institution Madrid Spain 28041
    46 Local Institution - 0045 Madrid Spain 28046
    47 Local Institution Santander Spain 39008
    48 Local Institution Sevilla Spain 41013
    49 Local Institution Valencia Spain
    50 Local Institution - 0050 Bristol Somerset United Kingdom BS2 8BJ
    51 Local Institution Birmingham United Kingdom B4 6NH
    52 Local Institution London United Kingdom NW1 2PG
    53 Local Institution Nottingham United Kingdom NG5 1PB
    54 Local Institution Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05255601
    Other Study ID Numbers:
    • CA224-069
    • 2021-000493-29
    • U1111-1264-4062
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 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
    Nivolumab

    Study Results

    No Results Posted as of Aug 18, 2022