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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02581228

Enrollment

500

Registered

2015-10-20

Start date

2015-10-31

Completion date

2018-11-30

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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.

Interventions

DEVICEML-PrediCare

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint in this study stage is Time to Progression of disease	1 year

Countries

Israel

Contacts

Primary ContactMarina Kleiman, PhD

marina@optimata.com972-7519226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026