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ARGO

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

CRUK logo

This trial was endorsed by Cancer Research UK (award reference no. C30423/A23607)

Find our more about ARGO on the Cancer Research UK website .