Multi-Centre, Retrospective, Open Label Study, to Validat... | NCT02581228

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

NCT02581228

Sponsor

Optimata Ltd.

Status

Unknown status

Last Update Posted

Sep 27, 2016Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Melanoma

Interventions

ML-PrediCare

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Apr 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Oct 19, 2015

First Submission Date that Met QC Criteria

Oct 19, 2015

First Posted Date

Oct 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ML-PrediCare	Device		Training Set Validation Set

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Marina Kleiman, PhD	Contact	972-7519226	112	marina@optimata.com

Name	Affiliation	Role
Marina Kleiman, PhD	Optimata Ltd.	Study Director
Michal Lotem, MD	Hadassah Medical Organization	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Optimata Ltd.	Recruiting	Bne ‘Atarot		60991	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31590677	Derived	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.

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type