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The University of Southampton
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

Open to recruitment

Population

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

Stand up to cancer logo
CONFIRM is supported by Stand Up To Cancer

Trial Team:

Senior Trial Manager:

Ellice Marwood (023 8120 5608)

Trial Manager:

Calley Middleton (023 8120 4307)

Clinical Data Coordinator:

Lucy Hogan (023 8120 5605)

Contact information:

Email: confirmtrial@soton.ac.uk

Fax: 0844 7740621

SAE Reporting: ctu@soton.ac.uk or 0844 7740621

Essential Trial Documents

CONFIRM - Protocol v6 07-Feb-2019

CONFIRM - PIS v5 19-Feb-2019

CONFIRM - Consent Form v5 14-Feb-2019

CONFIRM - Patient Contact Card 02-Feb-2017

CONFIRM - GP Letter v2 13-Feb-18

CONFIRM - Pregnancy Consent Form v1.0 18-Jan-2017

CONFIRM - Pregnant Partners Info Sheet v1 0 18-Jan-2017

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 - Blinding-unblinding process V1.0 07-Mar-2017

CONFIRM - Unblinding report form V1.0 24-Mar-2017

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

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 V2 10-Aug-2017

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

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

Nivolumab IB 17

Press releases, video clips and other external websites:

(University of Southampton cannot accept responsibility for external websites)

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