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

Optimata

Status: Unknown

Conditions: Melanoma

Treatments: Device: ML-PrediCare

Study type: Observational

Funder types: Industry

Identifiers

NCT02581228

OPTI-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No 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.

Trial design

500 participants in 2 patient groups

Training Set

Description:

The objective of the Training stage is to assess the predictive potential of ML-PrediCare for melanoma patients' response to Ipilimumab, Pembrolizumab and Nivolumab.

Treatment:

Device: ML-PrediCare

Validation Set

Description:

The objective of the Validation stage is to test the predictive power of ML -PrediCare in an independent set of patients diagnosed with melanoma.

Treatment:

Device: ML-PrediCare