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Southampton Clinical Trials Unit

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.

 

SU2C logo

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.

Trial Team:

Senior Trial Manager:

Denise Dunkley

Trial Manager:

Calley Middleton

Clinical Data Coordinator:

Kim Mallard

Data Manager:

Mike Radford

 

Contact information:

Email: confirmtrial@soton.ac.uk

SAE Reporting:

Email: ctu@soton.ac.uk

Essential Trial Documents

CONFIRM - Protocol v8 12-Mar-2021

CONFIRM - PIS v6 11-Jun-2020

CONFIRM - Consent Form v6 11-Jun-2020

CONFIRM - Patient Contact Card 02-Feb-2017

CONFIRM - GP Letter v2 13-Feb-18

CONFIRM - Pregnant Partner Consent Form v2 11.06.2020

CONFIRM - Pregnant Partners Info Sheet v2 11.06.2020

CONFIRM - Pregnant Patient Consent Form v1 11.06.2020

CONFIRM - Pregnant Patient Info Sheet v1 11.06.2020

 

Case Report Forms

CONFIRM - randomisation form V4 09-Nov-2018.pdf

CONFIRM - NHS Digital Patient Flagging Form v1 07-Sep-2017

CONFIRM - RECIST Report CRF V1 21-Sep-2017

CONFIRM - EQ-5D-5L Paper Self complete v1.0.docx

CONFIRM - Resource use questionnaire V2.0 31-Oct-2016.docx

 

ISF Documents

CONFIRM - Site Delegation Log v2 29-Mar-2017

CONFIRM - PI Protocol Acknowledgement Form

CONFIRM - Patient Screening Log V1.0 07-Mar-2017

CONFIRM - Master Patient List v1.0 07-Mar-2017

CONFIRM - Instructions for completion of Serious Adverse Event Reporting V2 14-Feb-2018

CONFIRM - Serious Adverse Event - SUSAR Report Form v4 06-Feb-2018

CONFIRM - Training Record V1.0 24-Mar-2017

CONFIRM - Site Visit Log V1.0 03-Nov-2016

CONFIRM - eCRF completion guidance V4 15-Nov-18.pdf

CONFIRM - Emergency Unblinding Notification Form V1 28-Sep-2020 

CONFIRM - Unblinding Procedures v1 28-Sep-2020

CONFIRM - Request for Non-Emergency Unblinding Form v1 28-Sep-2020

 

Translational Study Documents

CONFIRM - Laboratory Manual V4 10-Jun-2019

CONFIRM - Blood storage and shipment logs V1.0 13-Mar-2017

CONFIRM - Tissue Tracking Log V4 10-Jun-2019

 

IMP Documents

CONFIRM - Pharmacy Manual v4 26-Nov-2020

CONFIRM Nivolumab 100mg Accountability Log V2 10-Aug-17

CONFIRM Nivolumab-Placebo Dispensing Log V2 10-Aug-2017

Nivolumab IB v19

Nivolumab IB v19 addendum 01

Nivolumab IB v20

Fennell, D. A., et al. Nivolumab versus Placebo in Patients with Relapsed Malignant Mesothelioma (CONFIRM): a multicentre, double-blind randomised phase III trial. Lancet Oncology https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00471-X/fulltext

Fennell, D. A., et al. Nivolumab Versus Placebo in Relapsed Malignant Mesothelioma: Preliminary results from the CONFIRM Phase 3 Trial. Abstract for the Presidential Symposium of the World Conference on Lung Cancer 2021.

Press releases, video clips and other external websites:

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