search
Back to results

Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS (SOCRATES)

Primary Purpose

Melanoma, Atherosclerosis

Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Atorvastatin Calcium 40Mg Tab
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged > or equal to 40 years
  • diagnosis of stage 2, 3 or 4 melanoma treated with an ICI
  • not currently treated with a statin ,and
  • having acceptable imaging quality deemed by the core laboratory

Exclusion Criteria:

  • inability to provide informed consent
  • unwilling to be followed for serial evaluation
  • contra-indication or intolerance to statins
  • clinically manifest CV disease
  • prognostic factors associated with an expected survival less than 18 months (eg. un-resectable brain metastases)
  • severe liver disease or advanced renal disease (³stage 3b CKD or eGFR <45 ml/min)
  • any other factor that will preclude patients from participating in all study related activities

Sites / Locations

  • Monash HealthRecruiting
  • Cabrini HealthRecruiting
  • Latrobe Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Statin treatment

No statin treatment

Arm Description

Atorvastatin 40mg, daily, orally for 18 months

No comparator treatment/placebo allocated

Outcomes

Primary Outcome Measures

Change in non-calcified plaque volume according to treatment with statins
Difference in non-calcified plaque volume as measured on serial CTCA between patients treated with and without statin therapy

Secondary Outcome Measures

Change in total plaque volume in patients treated with ICI compared to historical cohorts
Difference in total plaque volume as measured on serial CTCA between patients treated with ICI therapy against historical cohorts
Change in pericoronary adipose tissue attenuation and volume according to treatment with statins
Difference in pericoronary adipose tissue attenuation and volume as measured on serial CTCA between patients treated with and without statin therapy
Cost-effectiveness of the use of CTCA as measured by net costs per life year gained in patients with melanoma treated with ICI therapy
Differences in cost-effectiveness ratios in terms of net costs per life year gained between patients with melanoma treated with ICI therapy who had CTCA performed compared to historical cohorts who did not have CTCA performed
Incidence of adverse events with statin therapy
Incidence and number of patients treated with and without statin therapy with reported adverse events and serious adverse events
Cost-effectiveness of statin therapy in patients with melanoma treated with ICI therapy as measured by net costs per life year gained
Difference in cost-effectiveness ratios between patients with melanoma on ICI therapy who are treated with and without statin therapy, in terms of net costs per life year gained
Effect of statins on depression in patients with melanoma treated with ICI therapy as measured on the Patient Health Questionnaire-9
Differences in mean changes in scores for the Patient Health Questionnaire-9 for each patient according to statin use, with a minimum score of 0 and a maximum score of 27, and higher scores indicating higher likelihood of depression
Effect of statins on anxiety in patients with melanoma treated with ICI therapy as measured on the Generalized Anxiety Disorder-7 questionnaire
Differences in mean changes in scores for the Generalized Anxiety Disorder-7 questionnaire for each patient according to statin use, with a minimum score of 0 and a maximum score of 21, and higher scores indicating higher likelihood of anxiety
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire
Differences in mean changes in scores for the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire for each patient according to statin use, with a minimum score of 30 and a maximum score of 126, and higher scores indicating poorer quality of life
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the EuroQoL Group EQ-5D questionnaire
Differences in mean changes in scores for the EuroQoL Group EQ-5D questionnaire for each patient according to statin use, with a minimum score of 1 and a maximum score of 15, and higher scores indicating poorer quality of life
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the FACT-M questionnaire
Differences in mean changes in scores for each section of the FACT-M questionnaire for each patient according to statin use. The score ranges for each individual section are: physical well-being 0-28, social well-being 0-28, emotional well-being 0-24, functional well-being 0-28, additional well-being 0-64, and melanoma-specific questions 0-32. Interpretation of scoring depends on the individual sections in the questionnaire, with higher scores in the physical, emotional, additional and melanoma-specific questions indicating poorer quality of life, whilst lower scores in the social and emotional questions indicate poorer quality of life

Full Information

First Posted
November 11, 2021
Last Updated
June 6, 2023
Sponsor
Monash University
Collaborators
National Health and Medical Research Council, Australia
search

1. Study Identification

Unique Protocol Identification Number
NCT05180942
Brief Title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Acronym
SOCRATES
Official Title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will incorporate a prospective randomised open blinded end-point trial in participants with stage 2, 3 or 4 melanoma treated with ICI to evaluate the impact of statin therapy on changes in coronary plaque burden and composition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statin treatment
Arm Type
Experimental
Arm Description
Atorvastatin 40mg, daily, orally for 18 months
Arm Title
No statin treatment
Arm Type
No Intervention
Arm Description
No comparator treatment/placebo allocated
Intervention Type
Drug
Intervention Name(s)
Atorvastatin Calcium 40Mg Tab
Intervention Description
One tablet daily
Primary Outcome Measure Information:
Title
Change in non-calcified plaque volume according to treatment with statins
Description
Difference in non-calcified plaque volume as measured on serial CTCA between patients treated with and without statin therapy
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in total plaque volume in patients treated with ICI compared to historical cohorts
Description
Difference in total plaque volume as measured on serial CTCA between patients treated with ICI therapy against historical cohorts
Time Frame
18 months
Title
Change in pericoronary adipose tissue attenuation and volume according to treatment with statins
Description
Difference in pericoronary adipose tissue attenuation and volume as measured on serial CTCA between patients treated with and without statin therapy
Time Frame
18 months
Title
Cost-effectiveness of the use of CTCA as measured by net costs per life year gained in patients with melanoma treated with ICI therapy
Description
Differences in cost-effectiveness ratios in terms of net costs per life year gained between patients with melanoma treated with ICI therapy who had CTCA performed compared to historical cohorts who did not have CTCA performed
Time Frame
18 months
Title
Incidence of adverse events with statin therapy
Description
Incidence and number of patients treated with and without statin therapy with reported adverse events and serious adverse events
Time Frame
18 months
Title
Cost-effectiveness of statin therapy in patients with melanoma treated with ICI therapy as measured by net costs per life year gained
Description
Difference in cost-effectiveness ratios between patients with melanoma on ICI therapy who are treated with and without statin therapy, in terms of net costs per life year gained
Time Frame
18 months
Title
Effect of statins on depression in patients with melanoma treated with ICI therapy as measured on the Patient Health Questionnaire-9
Description
Differences in mean changes in scores for the Patient Health Questionnaire-9 for each patient according to statin use, with a minimum score of 0 and a maximum score of 27, and higher scores indicating higher likelihood of depression
Time Frame
18 months
Title
Effect of statins on anxiety in patients with melanoma treated with ICI therapy as measured on the Generalized Anxiety Disorder-7 questionnaire
Description
Differences in mean changes in scores for the Generalized Anxiety Disorder-7 questionnaire for each patient according to statin use, with a minimum score of 0 and a maximum score of 21, and higher scores indicating higher likelihood of anxiety
Time Frame
18 months
Title
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire
Description
Differences in mean changes in scores for the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire for each patient according to statin use, with a minimum score of 30 and a maximum score of 126, and higher scores indicating poorer quality of life
Time Frame
18 months
Title
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the EuroQoL Group EQ-5D questionnaire
Description
Differences in mean changes in scores for the EuroQoL Group EQ-5D questionnaire for each patient according to statin use, with a minimum score of 1 and a maximum score of 15, and higher scores indicating poorer quality of life
Time Frame
18 months
Title
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the FACT-M questionnaire
Description
Differences in mean changes in scores for each section of the FACT-M questionnaire for each patient according to statin use. The score ranges for each individual section are: physical well-being 0-28, social well-being 0-28, emotional well-being 0-24, functional well-being 0-28, additional well-being 0-64, and melanoma-specific questions 0-32. Interpretation of scoring depends on the individual sections in the questionnaire, with higher scores in the physical, emotional, additional and melanoma-specific questions indicating poorer quality of life, whilst lower scores in the social and emotional questions indicate poorer quality of life
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged > or equal to 40 years diagnosis of stage 2, 3 or 4 melanoma treated with an ICI not currently treated with a statin ,and having acceptable imaging quality deemed by the core laboratory Exclusion Criteria: inability to provide informed consent unwilling to be followed for serial evaluation contra-indication or intolerance to statins clinically manifest CV disease prognostic factors associated with an expected survival less than 18 months (eg. un-resectable brain metastases) severe liver disease or advanced renal disease (³stage 3b CKD or eGFR <45 ml/min) any other factor that will preclude patients from participating in all study related activities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Butters
Phone
+61434679018
Email
julie.butters@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Nicholls, MBBS, PhD
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary-Anne Austin
Email
Maryanne.Austin@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Prof Stephen Nicholls
Facility Name
Cabrini Health
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivienne Nguyen
Email
ThuNguyen@cabrini.com.au
First Name & Middle Initial & Last Name & Degree
Prof Gary Richardson
Facility Name
Latrobe Regional Hospital
City
Traralgon
State/Province
Victoria
ZIP/Postal Code
3844
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Pongracic
Email
SPongracic@lrh.com.au
First Name & Middle Initial & Last Name & Degree
Dr Bhavini Shah

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The Steering Committee will decide if and how IPD will be shared. It is expected that study Co Investigators will be able to access data once the primary results have been presented.

Learn more about this trial

Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS

We'll reach out to this number within 24 hrs