NP39488 - Phase 1B RO7082859 & Atezolizumab in Non-Hodgkin's Lymphoma
Research type
Research Study
Full title
AN OPEN-LABEL, MULTI-CENTER, PHASE IB STUDY OF RO7082859 AND ATEZOLIZUMAB (PLUS A SINGLE PRE-TREATMENT DOSE OF OBINUTUZUMAB) IN ADULT PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA Sub-Study protocol: AN OPEN-LABEL, MULTI-CENTER, PHASE IB IMAGING SUB-STUDY OF GLOFITAMAB (PLUS A SINGLE PRE-TREATMENT DOSE OF OBINUTUZUMAB) USING 89ZR-DF-IAB22M2C ASCD8 TRACER IN ADULT PATIENTS WITH RELAPSED/REFRACTORY B-CELL NONHODGKIN’S LYMPHOMA
IRAS ID
249797
Contact name
Dr William Townsend
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-004835-36
Clinicaltrials.gov Identifier
CANC 39032, NIHR CRN Ref Number
Duration of Study in the UK
3 years, 7 months, 13 days
Research summary
Non-Hodgkin’s lymphoma (NHL) is cancer of the immune system (B-cells and T-cells) and a leading cause of cancer deaths. 80%–85% of all NHL cases are B-cell lymphomas of 2 sub-types: slow-growing (indolent) Follicular Lymphoma (FL) or more aggressive Diffuse Large B-cell Lymphoma (DLBCL).
Median survival in FL is 8–10years, however clinically advanced FL is incurable. 2-3% of patients with FL transform to aggressive DLBCL, per year. Median survival in untreated DLBCL is ~6months. Significantly prolonged survival in DLBCL has been observed in treatment with rituximab+chemotherapy, however ~50% of DLBCL patients relapse which carries a very poor prognosis.
Despite significant advances in immune-therapeutics, there remains an unmet medical need for safer, effective NHL therapies especially in the relapsed setting.
RO7082859 (T-cell bispecific antibody) targets B-cells to attack cancer cells. Atezolizumab targets receptors linked to cancer cells (PD-1 and PD-L1). Non-clinical data suggest increased anti-tumour activity in combinations of RO7082859+anti-PD-L1 agents, providing strong rationale for investigating the potential benefit of RO7082859+atezolizumab in NHL.
This is a 2-part global Phase1B, open-label study to investigate RO7082859+atezolizumab treatment in adult patients with NHL.
• Part 1 Dose Escalation: assess maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (“RP2D”) for combination treatment. 9-60 patients will be enrolled globally.
• Part 2 Dose Expansion: confirm the preliminary RP2D dose for future studies, investigate safety, tolerability, pharmacology, anti-tumour activity of combination treatment. 80 patients will be enrolled globally.
Sub-study: use of an injected tracer+scans to image the infiltration of B-cells in cancer cells after treatment with RO7082859.
Patients will receive treatment every 3 weeks (a cycle) for 8 cycles, unless they discontinue early. Patients who achieve a partial response/stable disease will receive 9 additional cycles of treatment. Following the last dose of treatment, all patients will enter into long-term follow-up.2 UK sites will participate in this study sponsored by F. Hoffmann-La Roche.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0282
Date of REC Opinion
29 Oct 2018
REC opinion
Further Information Favourable Opinion