Checkpoint blockade for inhibition of relapsed mesothelioma: A phase III trial to evaluate the efficacy of nivolumab in relapsed mesothelioma
Confirm is a double blind randomised phase III trial comparing nivolumab (anti-PD-1 antibody) monotherapy versus placebo in patients with mesothelioma.
Primary objective:
Secondary objectives:
Translational research:
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).
Closed to recruitment (31/03/2020)
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 .
Denise Dunkley
Calley Middleton
Data Manager:
Mike Radford
Email: confirmtrial@soton.ac.uk
Email: ctu@soton.ac.uk
CONFIRM - Protocol v8 12-Mar-2021
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
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
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
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
CONFIRM - Pharmacy Manual v4 26-Nov-2020
CONFIRM Nivolumab 100mg Accountability Log V2 10-Aug-17
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.
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