A phase III trial to evaluate the efficacy of Nivolumab in relapsed mesothelioma

Phase 1

• Conditions: Mesothelioma; MedDRA version: 20.0Level: PTClassification code 10027406Term: MesotheliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003111-35-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-03
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

1) Histological confirmation of mesothelioma
2) Prior treatment with at least one line of platinum based chemotherapy
3) ECOG Performance Status 0-1
4) Evidence of disease progression (which is radiologically assessable through RECIST) on CT scan
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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 186

Exclusion Criteria

Patients meeting the following criteria will be excluded:
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To determine whether nivolumab:<br>a) increases the length of time patients are free from disease (progression-free survival) <br>b) increases response rate to treatment<br>c) is safe and patients are able to tolerate the treatment <br>d) to ascertain how a patients PD-L1 status links with overall survival.<br>e) results in acceptable patient quality of life and cost per quality adjusted life year (QALY)<br>;Main Objective: This trial aims to determine whether nivolumab increases overall survival in patients with relapsed mesothelioma.;Primary end point(s): The primary outcome measure is overall survival calculated from the time of randomisation to the date of death and progression free survival;Timepoint(s) of evaluation of this end point: Calculated from the time of randomisation to the date of death

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) response rate <br>b) safety/tolerability <br>c) quality of life and cost per QALY<br>d) sensitivity to nivolumab with presence of PD-L1;Timepoint(s) of evaluation of this end point: a) time from randomisation to progression (according to RECIST), or death from any cause (whichever event comes first).<br><br>b) Time from randomisation to best response as determined by RECIST evaluation<br><br>c) Assessed using the CTCAE criteria to review adverse events from first treatment to to 30 days after last dose<br><br>d) Sample taken at baseline for central analysis. Results collated throughout trial.