Clinical trial · Observational
Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy
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
NCT02581228CI-TRIAL-00024047unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ML-PrediCare | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Device: ML-PrediCare
- label
- 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.
- interventionNames
- Device: ML-PrediCare
Primary outcomes (1)
- measure
- The primary endpoint in this study stage is Time to Progression of disease
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTsur 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. PMID 31590677