Condition category
Cancer
Date applied
27/02/2017
Date assigned
02/03/2017
Last edited
05/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mrs Kelly Cozens

ORCID ID

Contact details

Southampton Clinical Trials Unit
MP131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2016-003111-35

ClinicalTrials.gov number

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

Specialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs

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 measures

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

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

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

23/03/2021

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/04/2017: Cancer Help UK lay summary link added to plain English summary field