RiVa

Title

RiVa - A phase IIa study of Rituximab and Varlilumab in relapsed or refractory B-cell malignancies

Description

RiVa is a phase IIA clinical trial that evaluates the safety and efficacy of combining a direct tumour targeting antibody (rituximab) with a immunostimulatory antibody (varlilumab) for the treatment of patients with relapsed or treatment-refractory B-cell lymphoma.

Objectives

Primary Objectives:

• To document safety and tolerability of combined rituximab and varlilumab therapy.
• To document anti-tumour activity of combined rituximab and varlilumab therapy in relapsed or refractory B-cell

Secondary Objective:

• To measure the duration of response to rituximab and varlilumab over a follow-up period of 1 year.

Tertiary Objective:

• To assess the level of B-cell depletion in the peripheral blood and, where relevant, tumour site following therapy.
• To establish the proportion of immune effector cell populations in the peripheral blood and, where relevant, tumour site following therapy.
• To assess whether the expression of CD27 is associated with response in combined rituximab and varlilumab therapy.
• To ascertain whether co-administration of rituximab and varlilumab alters their pharmacokinetic properties.

Trial Design

This is a multicentre, randomised phase IIa trial in participants with relapsed or refractory CD20+B cell malignancies aiming to recruit 40 participants in total, with 20 participants in each of the following subcategories and 10 per treatment arm:

• Arm A - High grade lymphoma (DLBCL, FL grade 3b, transformed FL) (n=20)
• Arm B - Low grade lymphoma (e.g. FL grade 1, 2 or 3a, MZL, MCL, LPL) (n=20)

The trial will include a safety run in where 6-12 participants will be treated and the number of patients with dose limiting toxicities (DLTs) assessed. The trial will only progress to 40 participants if there are an acceptable number of DLTs in this safety run in.

Trial Status

In follow-up

Population

The study aims to recurit 40 Patients aged ≥16 years with relapsed or refractory B-cell lymphoma.

This trial is jointly funded by Cancer Research UK (award refence no. CRUKD/17/008) and Celldex Therapeutics.