MelanomaNCT02581228
Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy
An observational study of Melanoma, run by Optimata Ltd. at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma
- What is being tested?
- ML-PrediCare
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from up to about 500 melanoma patients will be screened for collection, depending on data availability and completeness of the files
Who may be able to join
- Patients who meet all of the following criteria are eligible for this study:
- Gender: Female, Male.
- Age: Eighteen years and older at the start of treatment.
- Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
- Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
- Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
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- Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.
- Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for melanoma.
Who cannot join
- Patients meeting one or more of the following criteria are ineligible for this study:
- 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
- Ocular melanoma
- Active brain metastases or leptomeningeal metastases.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Optimata Ltd.
Bne ‘Atarot, 60991
Marina Kleiman, PhD, 972-751-9226 ext. 112, marina@optimata.com
About this study
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
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.
- Conditions
- Melanoma
- Being tested
- ML-PrediCare
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-PrediCareDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ML-PrediCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this study stage is Time to Progression of disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optimata Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Kleiman, PhD, Study director, Optimata Ltd.Michal Lotem, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581228
- Sponsor's protocol ID
- OPTI-007
- Status last verified
- Sep 2016
- First submitted
- 19 Oct 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02581228
- Acronym / sponsor ID
- OPTI-007
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Optimata Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Set | – | Device: ML-PrediCareThe 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 | – | Device: ML-PrediCareThe objective of the Validation stage is to test the predictive power of ML -PrediCare in an independent set of patients diagnosed with melanoma. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from up to about 500 melanoma patients will be screened for collection, depending on data availability and completeness of the files
Key inclusion criteria (11 listed)
- Gender: Female, Male.
- Age: Eighteen years and older at the start of treatment.
- Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
- Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
- Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
Key exclusion criteria (5 listed)
- History of another malignancy within the previous 2 years except for:
- Ocular melanoma
- Active brain metastases or leptomeningeal metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ML-PrediCare | Device | Training Set, Validation Set |
Primary outcome
The primary endpoint in this study stage is Time to Progression of disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 31590677Tsur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Kleiman, PhD study director
Optimata Ltd.
Michal Lotem, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Optimata Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Kleiman, PhD (972-7519226 ext. 112, marina@optimata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint in this study stage is Time to Progression of disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02581228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.