CONFIRM

Title

Checkpoint blockade for inhibition of relapsed mesothelioma: A phase III trial to evaluate the efficacy of nivolumab in relapsed mesothelioma

Description

Confirm is a double blind randomised phase III trial comparing nivolumab (anti-PD-1 antibody) monotherapy versus placebo in patients with mesothelioma.

Objectives

Primary objective:

• To compare overall survival of nivolumab with placebo in patients with relapsed mesothelioma.

Secondary objectives:

• To compare progression free survival of nivolumab to placebo
• To compare overall response rate, as determined by investigator, of nivolumab to placebo
• To determine the safety profile of nivolumab in relapsed mesothelioma patients
• To define the association of PD-L1 status and OS in patients with relapsed mesothelioma
• To determine whether nivolumab results in acceptable quality of life and cost per QALY

Translational research:

• To determine the correlation between overall survival and i) PD-L1 expression, ii) mutational burden (estimated by genome-wide analysis of copy number alterations), iii) immunotranscriptomic profile.

Trial Design

A double blind randomised phase III trial comparing nivolumab (anti-PD-1 antibody) monotherapy versus placebo for one year. The treatment allocation ratio is 2:1 (treatment: placebo).

Trial Status

Closed to recruitment (31/03/2020)

Population

Mesothelioma patients (any subtype, pleural or peritoneal) who have undergone prior treatment with at least two different lines of therapy.

This research is funded by the Stand Up to Cancer campaign for Cancer Research UK (award reference no. C16728/A21400).

Find out more about the CONFIRM trial on the Cancer Research UK website .