Title
A phase II Study of Atezolizumab with Rituximab, Gemcitabine and Oxaliplatin in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma who are not candidates for High Dose Therapy
Description
ARGO is a phase II trial evaluating the addition of Atezolizumab to current therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) that are not candidates for high-dose therapy.
Objectives
Primary objective:
- To document the durable anti-tumour activity of R-GemOx-Atezo in patients with relapsed or refractory DLBCL.
Secondary objectives:
- To determine the safety and toxicity profile of R-GemOx-Atezo regimen.
- To document the anti-tumour activity of R-GemOx-Atezo in patients with relapsed or refractory DLBCL.
- To document the durability of R-GemOx-Atezo in patients with relapsed or refractory DLBCL.
- To determine the overall survival of patients treated R-GemOx-Atezo.
Tertiary objectives:
- To correlate clinical outcomes with gene expression analysis of PD-1, PD-L1, PD-L2 and other immune signatures from primary tumour material.
- To correlate clinical outcomes with immunohistochemical expression in tumour material of PD-1, PD-L1, PD-L2 and other markers in both tumour and microenvironment.
- To correlate clinical outcomes with expression of PD-1, PD-L1/L2 on peripheral blood T-cells. Sub division of T-lymphocyte sub-sets.
- To determine the profile of recurrent mutations observed in patients with DLBCL in this population and correlate to clinical response.
- To correlate clinical outcomes with known prognostic molecular features in DLBCL.
- To correlate clinical outcomes with cell of origin of DLBCL (ABC, GCB, unclassified).
- To examine use of plasma nucleic acid as a surrogate target in DLBCL and observation of dynamic change during study period.
- To examine the link between tumour-infiltrating T cell repertoire in pre-treatment biopsies and clinical outcomes.
Trial Design
This was a multicentre, randomised phase IIa trial in participants with relapsed or refractory DLBCL.
This study had two treatment arms.
All patients received one cycle of R-GemOx. Three quarters of patients (Arm B) went on to have a further 5 cycles (every 14 days) of R-GemOx with Atezolizumab, with one quarter of patients (Arm A) continuing with 5 cycles of R-GemOx.
The patients in Arm B continued to have Atezolizumab every 21 days for 8 cycles whilst Arm A patients entered an observational phase during this time.
Follow up began at 12 months from initial treatment until month 36.
Trial Status
Completed
Population
Patients aged ≥16 years with relapsed or refractory Diffuse Large B-Cell Lymphoma that are not candidates for high-dose therapy.
Contact Details
All trial enquiries should be sent to ctu@soton.ac.uk
Publications
Poster presentation at the International Conference on Malignant Lymphoma, June 2021
Funding
This trial was endorsed by Cancer Research UK (award reference no. C30423/A23607)
Find our more about ARGO on the Cancer Research UK website.