Phase 1b of MPDL3280A + Obinutuzumab in Folicular and B-cell lymphoma
Research type
Research Study
Full title
A PHASE IB STUDY OF THE SAFETY AND PHARMACOLOGY OF MPDL3280A ADMINISTERED WITH OBINUTUZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA AND DIFFUSE LARGE B-CELL LYMPHOMA
IRAS ID
173396
Contact name
John Gribben
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2014-001812-21
Duration of Study in the UK
years, months, days
Research summary
This is a Phase Ib, open-label, multicenter, global study designed to assess the safety, tolerability, preliminary efficacy, and PK of intravenous (IV) dosing of MPDL3280A and obinutuzumab administered in combination to patients with refractory or relapsed Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL). There are two stages of this study: The Safety Evaluation Stage (Stage 1) and the Expansion Stage (Stage 2).
Stage 1 is designed to establish the safety and tolerability of MPDL3280A in combination with obinutuzumab. There is no dose-finding component for MPDL3280A in combination with obinutuzumab in this study; rather, the optimal schedule of the combination is being evaluated. Based on the optimal schedule of the combination treatment established in Stage 1, a potential recommended phase 2 dose (RP2D) and schedule will be investigated in Stage 2 with two expansion cohorts of patients with refractory or relapsed FL and DLBCL. Patients in Stage 2 will also undergo mandatory tumour tissue collection for biopsy at various time points. Anti-tumour activity assessments will be performed following three cycles of combination treatment, at the completion of combination treatment, and every three months in the first year followed by every six months thereafter until PD, death, or withdrawal of consent.
For patients who continue to demonstrate a response to treatment, the full tumour assessment is obtained 6−8 weeks after study treatment is discontinued and every three months in the first year followed by every six months thereafter until PD, death, or withdrawal of consent. Treatment with MPDL3280A may be continued until PD or no longer receiving clinical benefits. In the absence of progression, obinutuzumab may be continued for a maximum of 8 cycles. Future amendments might include changes to the treatment schedule, additional therapeutic options in combination with MPDL3280A and obinutuzumab, and/or additional diseases studied with MPDL3280A and obinutuzumab.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0599
Date of REC Opinion
29 May 2015
REC opinion
Further Information Favourable Opinion