Clinical trial NCT02581228: Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Lead sponsor: Optimata Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data from up to about 500 melanoma patients will be screened for collection, depending on data availability and completeness of the files

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint in this study stage is Time to Progression of disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bene-Atarot
country: Israel
facility: Optimata Ltd.
Study officials:
affiliation: Optimata Ltd.
name: Marina Kleiman, PhD
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organization
name: Michal Lotem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsur N, Kogan Y, Avizov-Khodak E, Vaeth D, Vogler N, Utikal J, Lotem M, Agur Z. Predicting response to pembrolizumab in metastatic melanoma by a new personalization algorithm. J Transl Med. 2019 Oct 7;17(1):338. doi: 10.1186/s12967-019-2081-2.