Phase I study of Urelumab in solid tumours & B-NHL (BMS CA186-011)
Research type
Research Study
Full title
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects with Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma (B-NHL) [UK will participate in Part 4 of the protocol only]
IRAS ID
164877
Contact name
Milagros Blazquez
Contact email
Sponsor organisation
BristolMyers Squibb International Corporation
Eudract number
2012-000170-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 17 days
Research summary
This is a multicentre phase 1 study to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of Urelumab in cancer patients with advanced and/or metastatic tumours and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL). Urelumab is an experimental drug currently in development as a new type of immunotherapy which may stimulate the body’s immune system to help attack cancer cells.
The study has four parts. Part 1 is a dose escalation assessment in patients with advanced and/or metastatic solid tumours, Part 2 is a cohort expansion of the tolerable dose, Part 3 is for patients with three specific tumour types to be treated at the maximum tolerated dose and Part 4 will recruit approximately 50 B-NHL patients to be treated at a fixed dosing regimen. Patients in the UK will only participate in Part 4 as recruitment is complete for Parts 1-3.
In Part 4 patients will receive Urelumab intravenously every 3 or 6 weeks for 24 weeks.
Patients will undergo the following study procedures: tumour biopsy, CT/MRI scans, PET scans, physical examinations, vital signs (blood pressure, height, weight, body temperature) and bloods for routine safety and study specific testing.
After the treatment period patients will be followed-up for 60 days (including at least 2 clinic visits) and then telephoned every 12 weeks for 3 years to collect survival data.
If a patient is still responding to the treatment after the 60 day follow up they will enter the ‘response follow up’ period which involves a scan every 12 weeks for 1 year then every 12-24 weeks for a second year then approximately every 24 weeks until they start a new treatment, have tumour progression, they withdraw consent or the study stops.
The study will be conducted by trained oncology teams in specialised NHS clinics. The study is sponsored by Bristol-Myers Squibb.REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1848
Date of REC Opinion
1 Dec 2014
REC opinion
Further Information Favourable Opinion