RELATIVITY-069

• Research type

  Research Study

• Full 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

• IRAS ID

  1004783

• Contact name

  Head of the Global Submission Management - Clinical Trials

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2021-000493-29

• Research summary

  The purpose of conducting this clinical trial is to learn more about the safety and effectiveness of relatlimab and nivolumab. In the treatment of Recurrent or Refractory Classical Hodgkin Lymphoma (CHL) and Non-Hodgkin Lymphoma (NHL).
  NHL is third in the list of most common childhood cancers constituting 10% to 12% of cancers in children. Although the outcome for NHL at diagnosis is favourable using treatment strategies that are tailored to the specific patient and disease, those with recurrent or refractory disease do not do well. Treatment is not consistent in their approach and there is no recommendation on the best approach.

  There are 2 parts to this study. In Part A, different doses of relatlimab and nivolumab will be given together to learn more about the safety of the study drug combination in participants with cHL and NHL. In Part B, participants will receive nivolumab and relatlimab at the dose that was chosen from Part A. Part B will look at how effective the study drug combination is in participants with recurrent/relapsed or refractory cHL and NHL participating.

  The study is divided into 3 periods: a screening period, a treatment period, and a follow-up period.
  The clinical trial will be conducted in approximately 50 centres in 7 countries with at least 10 children and young adults with recurrent/relapsed or refractory cHL and NHL participating in Part A and up to 66 participants with recurrent/relapsed or refractory cHL and NHL participating in Part B.

  The age range of participants in part A of this trial are from 0 to 18 and for Part b 0-30.

  The clinical trial will be conducting in hospitals.

  The expected duration of the trial is expected to be approximately 5 years

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  23/EM/0047

• Date of REC Opinion

  13 Sep 2023

• REC opinion

  Further Information Favourable Opinion