Plain English Summary
Trial website
Additional identifiers
EudraCT number
2016-003111-35
ClinicalTrials.gov number
NCT03063450
Protocol/serial number
32290
Study information
Scientific title
CheckpOiNt blockade For Inhibition of Relapsed Mesothelioma (CONFIRM): A Phase III Trial to Evaluate the Efficacy of Nivolumab in Relapsed Mesothelioma
Acronym
CONFIRM
Study hypothesis
The aim of this study is to compare overall survival of nivolumab with placebo in patients with relapsed mesothelioma.
Ethics approval
West Midlands - Edgbaston Research Ethics Committee, 06/12/2016, ref: 16/WM/0472
Study design
Randomised; Interventional; Design type: Treatment, Drug, Immunotherapy
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Mesothelioma
Intervention
Patients will be randomised 2:1 to nivolumab or placebo, with twice as many people getting nivolumab as placebo. Randomisation will be stratified by site and epithelioid vs. non-epithelioid.
Active treatment arm: Patients will be treated with nivolumab at a dose of 240mg, every two weeks, infused over 30 minutes until disease progression, to a maximum of 12 months.
Placebo control arm: Patients will receive a placebo consisting of sterile 0.9% sodium chloride, every two weeks, infused over 30 minutes until disease progression, to a maximum of 12 months.
All patients will be followed up for a minimum 6 months and maximum of 5 years.
Intervention type
Drug
Phase
Phase III
Drug names
Nivolumab
Primary outcome measure
Overall survival will be calculated as time from randomisation until date of death
Secondary outcome measures
1. Progression free survival is calculated as time from randomisation to disease progression by RECIST 1.1 or modified RECIST using CT scans at baseline compared to further CT scans after cycles 3 and 6 (each cycle is 14 days)
2. Overall response rate is measured by RECIST 1.1 or modified RECIST using CT scans at baseline compared to further CT scans after cycles 3 and 6 (each cycle is 14 days)
3. Quality of life is measured using EQ-5D-5L at baseline, after cycles 3 and 6 (each cycle is 14 days) and 1, 6 and 12 months post progression/treatment discontinuation
4. Toxicity is measured using CTCAE V4.03 at baseline, after each treatment cycle (each cycle is 14 days) and each follow up visit
5. Cost effectiveness is measured using a health resource use questionnaire at baseline, after cycles 3 and 6 (each cycle is 14 days) and 1, 6 and 12 months post progression/treatment discontinuation
Overall trial start date
01/10/2016
Overall trial end date
30/09/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histological confirmation of mesothelioma
2. Prior treatment with at least two lines of platinum based chemotherapy
3. ECOG Performance Status 0-1
4. Evidence of disease progression (which is radiologically assessable through RECIST) on CT scan within 28 days of trial treatment
5. Age 18 and above
6. Screening laboratory values within protocol specified ranges
7. Willing to use adequate contraception methods where applicable
8. Willing to provide blood and tissue samples relating to mesothelioma
9. Expected survival of at least 12 weeks
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 336; UK Sample Size: 336
Total final enrolment
332
Participant exclusion criteria
1. Untreated, symptomatic CNS metastases
2. Carcinomatous meningitis
3. Active, known or suspected auto-immune disease
4. Those requiring systemic treatment with corticosteroids or immunosuppressive medications within 14 days of planned first dose
5. Other active malignancy requiring treatment
6. Serious or uncontrolled medical disorder or active infection which would impact on the trial or affect their involvement
7. Prior treatment with anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody
8. History of testing positive for HIV or AIDS or a positive test for Hepatitis indicating acute or chronic infection
9. History of allergy or sensitivity to monoclonal antibodies
10. Women who are pregnant or breastfeeding
Recruitment start date
27/03/2017
Recruitment end date
27/03/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton Clinical Trials Unit
MP131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University of Southampton
Sponsor details
Research & Innovation Services
University Road
Southampton
SO17 1BJ
United Kingdom
+44 23 8059 8673
rgoinfo@soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results of the trial will be published in a high-impact peer reviewed scientific journal around six months after overall trial end date.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available for sharing via controlled access by authorised Southampton CTU (SCTU) staff (as delegated to SCTU by the trial sponsor) and anonymised IPD within the clinical trial dataset will be available for sharing via open access after the trial is published.
Intention to publish date
30/09/2022
Participant level data
Available on request
Basic results (scientific)
Publication list