NP40126 - A Phase 1B Study Evaluating RO7082859 in Lymphoma
Research type
Research Study
Full title
A PHASE 1B STUDY EVALUATING RO7082859 IN COMBINATION WITH RITUXIMAB (R) OR\nOBINUTUZUMAB (G) PLUS CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE (CHOP) IN PARTICIPANTS WITH RELAPSED REFRACTORY FOLLICULAR LYMPHOMA (R/R FL) OR IN PARTICIPANTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA
IRAS ID
238968
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-003648-18
Clinicaltrials.gov Identifier
CANC 36899, NIHR CRN Reference Number
Duration of Study in the UK
5 years, 1 months, 17 days
Research summary
Non-Hodgkin lymphoma (NHL) is cancer of the immune system (B-cells and T-cells) and one of the leading causes of cancer deaths in Europe and the USA. 80%–85% of all NHL cases are B-cell lymphomas. B-cell lymphoma sub-types include slow-growing Follicular Lymphoma (FL) and more aggressive Diffuse Large B-cell Lymphoma (DLBCL).\n\nFL accounts for about 22% of newly-diagnosed NHL cases. Despite prolonged responses and improved patient outcomes with treatment using immuno-chemotherapy [for example Rituximab plus a chemotherapy regimen (together known as “R-CHOP”)], FL remains incurable. A significant number of patients relapse or die from disease progression or treatment-related toxicity. Patients with FL and DLBCL who relapse after receiving several prior treatments have limited treatment options.\n \nT-cell bispecific (TCB) antibodies – such as RO7082859 – represent a new class of disease-targeting agents that promote activation of a patient’s immune system to attack and kill cancer cells. A combination of RO7082859 with R-CHOP in patients with relapsed/refractory (r/r) FL may provide an opportunity for significant clinical benefit for patients. \n\nThis is a 2-part Phase IB study.\n\nPart I Dose Escalation will explore different doses of RO7082859 with R-CHOP, to determine the maximum tolerated dose in participants with r/r FL (15-60 participants globally). Participants will have treatment once every 3 weeks (a cycle) for 6 cycles (approximately 5 months). \n\nPart II Dose Expansion will further assess this combination of RO7082859 with immuno-chemotherapy, in participants with untreated DLBCL and participants with r/r FL (102 participants globally). Participants with DLBCL will be treated for 8 cycles. Participants with r/r FL will be treated for 6 cycles. \n\nThe study will last approximately 5 years. There will be 2 UK sites participating in Part I, and additional UK sites added in Part II in early 2019. \n\nThis study is sponsored by F. Hoffman La Roche.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0396
Date of REC Opinion
16 May 2018
REC opinion
Further Information Favourable Opinion