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

• Conditions: Melanoma
• Interventions: Device: ML-PrediCare

• Registration Number: NCT02581228
• Lead Sponsor: Optimata Ltd.

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27
• Primary Completion: 2018-04
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training Set	ML-PrediCare	The objective of the Training stage is to assess the predictive potential of ML-PrediCare for melanoma patients' response to Ipilimumab, Pembrolizumab and Nivolumab.
Validation Set	ML-PrediCare	The objective of the Validation stage is to test the predictive power of ML -PrediCare in an independent set of patients diagnosed with melanoma.

Primary Outcome Measures

Name	Time	Method
The primary endpoint in this study stage is Time to Progression of disease	1 year

Trial Locations

Locations (1)

Optimata Ltd.; 🇮🇱 Bene-Atarot, Israel