Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy

Melanoma Clinical Trial

Official title:

Multi-centre, Retrospective, Open Label Study, to Establish and Validate ML-PrediCare for Patients of Advanced Melanoma Undergoing Immunotherapy, as a 1st, 2nd and Later Lines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02581228
• Other study ID #: OPTI-007
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2015
• Last updated: September 26, 2016
• Start date: October 2015
• Est. completion date: November 2018

Study information

• Verified date: September 2016
• Source: Optimata Ltd.
• Contact: Marina Kleiman, PhD
• Phone: 972-7519226
• Email: marina[@]optimata.com
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This is a retrospective, open label study to establish and validate a prediction technology for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the immunotherapeutic drugs Ipilimumab, Pembrolizumab & Nivolumab, in order to predict response rate and disease progression

Description:

The aim of this project is to develop a technology application (termed ML-PrediCare), which is meant to be a predictive stand-alone software device, to support clinicians' decision-making, by predicting the individual patient's response to immunotherapy treatments, e.g., in terms of time-to-progression (TTP).

In Stage I of the study, data will be collected for establishing a training set and assess the predictive potential of the modelling technology for the response of melanoma patients to immunotherapy. In Stage II of the study, data will be collected in order to establish a validation set and test the predictive power of the modelling technology in an independent set of patients diagnosed with melanoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for this study:

1. Gender: Female, Male.

2. Age: Eighteen years and older at the start of treatment.

3. Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.

4. Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.

5. Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1

6. Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.

7. Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.

8. Patient has at least one recorded visit to the treating oncologist before treatment.

9. Patient has at least one recorded visit to the treating oncologist during or after the treatment.

10. Treatment as per SOC for melanoma.

Exclusion Criteria:

Patients meeting one or more of the following criteria are ineligible for this study:

1. History of another malignancy within the previous 2 years except for:

• Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years

2. Ocular melanoma

3. Active brain metastases or leptomeningeal metastases.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Melanoma

Intervention

Device:
• ML-PrediCare

Locations

Country	Name	City	State
Israel	Optimata Ltd.	Bene-Atarot

Sponsors (1)

Lead Sponsor	Collaborator
Optimata Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint in this study stage is Time to Progression of disease		1 year	No