CA209-744: Nivolumab and brentuximab vedotin for cHL
Research type
Research Study
Full title
Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation
IRAS ID
218752
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-002347-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 0 days
Research summary
This is a study of nivolumab and brentuximab vedotin for children, adolescent and young adults with classic Hodgkin lymphoma who have failed previous therapy, followed by brentuximab and bendamustine for those who did not achieve an optimal response.
Approximately 100 patients will take part globally, 8 of these will be in the UK. The study is sponsored by Bristol-Myers Squibb. The purpose of the study is to evaluate the safety and anti-tumour activity of combination therapy with nivolumab and brentuximab vedotin in a population of patients who have failed standard frontline chemotherapy.
While the treatment of classic Hodgkin lymphoma has improved dramatically over the past 20 years, with 5 year event free survival rates close to 90%, there is still a group of patients who either relapse or in whom first-line treatment fails. These patients currently have a poor outcome and there is currently an unmet need to improve the prognosis of this group of patients.
Following a screening period, eligible patients will be given nivolumab and brentuximab vedotin every 3 weeks and for patients with a poor response to treatment, they may receive intensification with brentuximab vedotin and bendamustine. Treatment will be given every three weeks and will be given 4 to 8 times in total. They may receive further treatments, in accordance with standard of care, such as involved field radiation therapy and high-dose chemotherapy/autologous stem cell transplant thereafter. Patients will be followed up for 3 years after they stop study treatment.
Patients will undergo the following study procedures: Tumour biopsy (if not already available), imaging scans, physical exams, vital signs such as blood pressure, height, weight, body temperature and blood tests for safety testing and study specific testing. They will also be required to complete questionnaires at regular intervals to assess their quality of life.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0168
Date of REC Opinion
28 Apr 2017
REC opinion
Further Information Favourable Opinion