Ph 1b MEDI4736 for Relapsed/Refractory Diffuse Large B-cell Lymphoma
Research type
Research Study
Full title
A Phase 1b Study to Evaluate the Safety and Efficacy of MEDI4736 as Monotherapy and in Combination with Tremelimumab or AZD9150 in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma
IRAS ID
191745
Contact name
Martin J. S. Dyer
Sponsor organisation
MedImmune LLC
Eudract number
2015-002215-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 25 days
Research summary
Non-Hodgkin’s lymphoma (NHL) is the 6th most common cancer in the US, with diffuse large B-cell lymphoma (DLBCL) being the most common. Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably.
Research has shown that in some patients, cancer cells and immune cells start to express signals that stop the body’s immune system from killing the cancer. MEDI4736, tremelimumab and AZD9150 are new experimental drugs being developed to block these signals and to increase the immune response to help prevent or slow down growth of cancer cells. MEDI4736 and tremelimumab are antibodies, and AZD9150 an antisense oligonucleotide (short sequence of nucleic acids) each designed to target a different signal.
This phase 1b, open-label, study is in patients with DLBCL and will occur in two parts. Part 1 will determine the dose of MEDI4736 when given in combination with tremelimumab or AZD9150 that is safe and tolerable, and Part 2 will continue to assess the safety and tolerability of MEDI4736 when given alone, or together with tremelimumab or AZD9150 in patients with DLBCL.
The study will involve a screening period (approx 1 month), treatment period (up to 1 year) and a follow-up period (approx 3 years).
A number of different tests will need to be done to determine if these drugs work, learn what side effects there might be, how much of each drug is in the blood at various times, whether the immune system becomes activated following treatment or the body produces antibodies against any of the drugs, as well as what effect these drugs have on cancer. These include tumour biopsies, physical exams, ECGs, blood and urine analyses, as well as PET/CT and MRI scans.
Approximately 186 participants will be enrolled at 20 different research sites globally.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0521
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion