Clinical trial · Observational
Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice
prospectIve Non-interventional Study of Clinical Outcomes And Biomarkers in Patients With Stage 0-IV mElanoma in reaL clinicaL prActice
NCT05402059CI-TRIAL-00059093ISABELLAunknownClinicalTrials.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)
Prospective non-interventional study of clinical outcomes and biomarkers in patients with stage 0-IV skin melanoma in real clinical practice
Conditions
Conditions (8)
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 |
| Melanoma in Situ | Melanoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Melanoma, Ocular | Ocular Melanoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Melanoma, Stage II | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma Stage III | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma Stage IV | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma, Uveal | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Cohort A
- description
- Study Cohort A will include patients with unresectable and/or metastatic melanoma, regardless of BRAF mutation in the tumor, who were started on any of the drug regimens in accordance with current clinical guidelines, except for patients assigned to the vemurafenib + cobimetinib + atezolizumab, which should be included in the A1 cohort. The initiation of therapy on the regimen that will be used at the time of signing the informed consent will be considered an index event.
- interventionNames
- Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- label
- Cohort A1
- description
- Study Cohort A1 will include patients with unresectable and/or metastatic melanoma and an activating BRAF mutation in the tumor who were treated with vemurafenib + cobimetinib + atezolizumab, either newly diagnosed or progressing during previous lines of therapy. Initiation of vemurafenib + cobimetinib + atezolizumab would be considered an index event.
- interventionNames
- Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: General inclusion criteria (all cohorts): * male or female patients 18 years of age or older; * ECOG status \<=3; * the current treatment regimen (index date) was started no earlier than 12 weeks (84 days) prior to obtaining written informed consent to participate in this study; * patients who are willing and able to participate in the study; * informed consent to participate in the study was obtained. Inclusion criteria for cohort A: -Confirmed by histopathology cutaneous melanoma stage IV metastatic cutaneous melanoma (or IIIC/D unresectable stage or cutaneous melanoma metastases without a primary lesion or equivalent) with or without a BRAF mutation for which the attending physician has decided to initiate any systemic or local treatment before inclusion in the study; Inclusion criteria for cohort A1: * Confirmed by histopathology stage IV (or unresectable stage IIIC/D or non-resectable cutaneous melanoma metastases or equivalents) with a confirmed BRAF mutation for which the treating physician has decided to initiate treatment with vemurafenib + cobimetinib + atezolizumab before inclusion in study; * treatment with vemurafenib + cobimetinib + atezolizumab was started no earlier than 12 weeks (84 days) prior to obtaining written informed consent to participate in this study; Inclusion criteria for cohort B: \- Confirmed by histopathology melanoma of the skin with regional lymph node involvement, transit or satellite metastases (equivalent to IIIA, B, C/D resectable stage) with or without a BRAF mutation, for which the attending physician decided to start any systemic or local treatment before enrollment in the study ; Inclusion criteria for cohort C: * Confirmed by histopathology melanoma of the skin melanoma of the skin without involvement of regional lymph nodes, without clinically or morphologically determined transit or satellite metastases (equivalent to 0-IIC resectable stage) with or without a BRAF mutation, about which the attending physician has decided to start any systemic or local treatment before inclusion in the study; * Skin melanoma thicker than 0.8 mm Breslow was staged with a sentinel lymph node biopsy procedure; Inclusion criteria for cohort D: • Confirmed by histopathology or cytology non-cutaneous melanoma of any stage (including but not limited to patients with melanoma of the mucous membranes of the upper respiratory and digestive tract, anal canal, female and male genital organs, choroid), for which the attending physician has decided to start any systemic or topical treatment before inclusion in the study; Exclusion Criteria: * Patients with a life expectancy of less than 1 month at the time of diagnosis of melanoma, according to the investigator. * Patients enrolled in any interventional clinical trial involving the use of experimental drugs or drugs available over the counter at the time of enrollment in the study. (Patients enrolled in another investigator-initiated study or non-interventional study may be included in this study if it does not involve changes to their standard of care.) * Patients with no histologically confirmed diagnosis of melanoma and who are receiving active treatment for cancers other than melanoma at the time of enrollment. Patients with multiple primary synchronous or metachronous tumors, at least one of which is melanoma, may be included in the study.
References
Publications (1)
- DERIVEDSamoylenko IV, Kolontareva YM, Kogay EV, Zhukova NV, Utyashev IA, Ivannikov ME, Menshikov KV, Zinkevich MV, Orlova KV, Vakhabova YV, Volkonsky MV, Beliaeva NA, Butkov II, Karabina EV, Moskovkina TL, Moshkova KA, Plishkina OV, Sychev VD, Cheplukhova OS, Chernova VV, Yurchenkov AN, Babina KG, Savelov NA, Demidov LV. Triple combination of vemurafenib, cobimetinib, and atezolizumab in real clinical practice in the Russian Federation: results of the A1 cohort of the ISABELLA study. Front Oncol. 2024 Oct 14;14:1395378. doi: 10.3389/fonc.2024.1395378. eCollection 2024. PMID 39469641