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Status unknownNCT02581228Updated Sep 27, 2016

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

An observational study in Melanoma, sponsored by Optimata Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by Optimata Ltd. · Observational

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 120 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Melanoma

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In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's planned enrollment of 500 is above the median of 182 across 448 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Optimata Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Training Set

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

    Device: ML-PrediCare

  • Validation Set

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

    Device: ML-PrediCare

Interventions

  • DeviceML-PrediCare
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What researchers measure

Primary outcomes

  1. The primary endpoint in this study stage is Time to Progression of disease

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Optimata Ltd.
    Bne ‘Atarot, 60991, Israel
    Recruiting
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References and documents

Publications

  • 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. PubMed 31590677 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2015, a primary completion of Apr 2018 and a completion of Nov 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2015
First posted
Oct 20, 2015
Start
Oct 2015
Primary completionEst.
Apr 2018
CompletionEst.
Nov 2018
Last update
Sep 27, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02581228
Lead sponsor
Optimata Ltd.
Responsible party
Sponsor
First posted
Oct 20, 2015
Start date
Oct 2015
Primary completion
Apr 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Sep 27, 2016

Study contacts

Marina Kleiman, PhD
Contact
marina@optimata.com
972-7519226 ext. 112
Marina Kleiman, PhD
study director · Optimata Ltd.
Michal Lotem, MD
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Optimata Ltd.

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