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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 (RELATIVITY-069)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05255601
Recruitment Status : Not yet recruiting
First Posted : February 24, 2022
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Lymphoma, Non-Hodgkin Hodgkin Disease Drug: Relatlimab Drug: Nivolumab Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Relatlimab + Nivolumab Drug: Relatlimab
Specified Dose on Specified Days
Other Name: BMS-986016

Drug: Nivolumab
Specified Dose on Specified Days
Other Name: BMS-936558




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05255601


Contacts
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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
Show Show 54 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05255601    
Other Study ID Numbers: CA224-069
2021-000493-29 ( EudraCT Number )
U1111-1264-4062 ( Registry Identifier: WHO )
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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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:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action