CA209-436 Nivolumab with Brentuximab Vedotin in Non-Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination with Brentuximab Vedotin in Subjects with Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression
IRAS ID
198592
Contact name
Sharan Chowdhury
Contact email
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2015-003286-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This is a multicentre, phase I/II study involving the combination of two investigational drugs called nivolumab and brentuximab vedotin. This study will include patients with certain types of Non-hodgkin lymphoma. The purpose of the study is to determine if this combined treatment will result in clinical benefits in these patients, who have failed at least one prior line of chemotherapy and whose cells express a certain amount of a protein called CD30 on their surface.
Approximately 120 patients will take part globally, of which around 6 will be enrolled in the UK. The study is sponsored by Bristol-Myers Squibb.
Following a screening period, eligible patients will receive both drugs intravenously (through the vein) in treatment cycles that are 3 weeks long. In cycle one, brentuximab vedotin will be given on cycle 1, day 1 and nivolumab will be given on cycle 1, day 8. Subsequent to cycle 1, both drugs will be administered on day 1 of each cycle.
Patients will undergo the following study procedures: tumour biopsy (if one is not already available), CT/MRI/FDG PET-CT scans, physical exams, vital signs (blood pressure, height, weight, blood tests and urine samples for routine safety testing and study specific testing). Patients will also be required to complete a quality of life questionnaire at regular intervals throughout the study. Patients may remain in the study for as long as they are tolerating the treatment (if they experience toxicity from one drug but demonstrate clinical benefit from the other, they may continue treatment with the single drug that appears to be providing benefit to them) or until it has been confirmed that their cancer has worsened. At the conclusion of the study, patients who continue to gain clinical benefit and are tolerating the study drug will be eligible to continue receiving the study drugs.REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0207
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion