Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice
ISABELLA
prospectIve Non-interventional Study of Clinical Outcomes And Biomarkers in Patients With Stage 0-IV mElanoma in reaL clinicaL prActice
1 other identifier
observational
1,570
1 country
1
Brief Summary
Prospective non-interventional study of clinical outcomes and biomarkers in patients with stage 0-IV skin melanoma in real clinical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2022
CompletedFirst Submitted
Initial submission to the registry
May 29, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJune 15, 2022
June 1, 2022
2.1 years
May 29, 2022
June 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
12-month relapse-free survival
The primary efficacy endpoint of the study is 12-month relapse-free survival, defined as the time from index date to the date of first documented relapse or death from any cause (for stage 0-III asymptomatic patients with or without adjuvant therapy, cohorts B and C).
12 months
12-month progression free survival
The second primary efficacy endpoint is the 12-month PFS, defined as the time from the index date to the date of the first documented investigator-determined progression or death from any cause. If the patient has not experienced an event, PFS will be censored at the date of the last tumor assessment (for patients with IIIC/D unresectable or metastatic melanoma, cohorts A, A1, D).
12 months
Study Arms (5)
Cohort A
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.
Cohort A1
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.
Cohort B
Study Cohort B will include patients with stage III equivalent skin melanoma (i.e., regional lymph node involvement), regardless of tumor BRAF mutation, who have undergone surgery (lymphadenectomy, SLNB, or metastasectomy) and/or initiated or planned treatment according to any of the drug therapy regimens or only dynamic observation, in accordance with current clinical guidelines. Surgery for stage III melanoma will be considered an index event.
Cohort C
Study cohort C will include patients with stage 0-II equivalent skin melanoma (i.e., no regional lymph node involvement), regardless of BRAF mutation in the tumor, who have undergone surgery (excision of the primary tumor +/- SLNB) and/ or initiated or planned treatment for any of the drug regimens or only dynamic observation, in accordance with current clinical guidelines. Surgical treatment (operation) for stage 0-II melanoma will be considered an index event.
Cohort D
Study cohort D will include patients with stage 0-IV non-cutaneous melanoma, regardless of the BRAF mutation in the tumor, who underwent morphological verification of the diagnosis, surgery (any volume) and / or treatment initiated or planned for any of the drug therapy regimens or only dynamic observation, in accordance with current clinical guidelines. Initiation of therapy according to the regimen that will be used at the time of signing of informed consent or surgical treatment will be considered an index event.
Interventions
Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice
Eligibility Criteria
Study will be conducted in investigation sites specialized in treatment of solid neoplasm or, more narrowed, melanoma. Patient may be enrolled either by surgical or medical oncologist if relevant indormation is available and there is no obvious risk for loss of contact with patient. Study population will be formed of the patients from cancer treatment facilities and the representativeness of sample may vary depending on participating sites.
You may qualify if:
- 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.
- 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;
- \- 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 ;
- Skin melanoma thicker than 0.8 mm Breslow was staged with a sentinel lymph node biopsy procedure;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
N.N. Blokhin Russian Cancer Research Center
Moscow, 115522, Russia
Related Publications (1)
Samoylenko 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: 39469641DERIVED
Biospecimen
Formalin fixed paraffin embedded tumor tissue blocks
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2022
First Posted
June 2, 2022
Study Start
March 2, 2022
Primary Completion
April 1, 2024
Study Completion
April 1, 2025
Last Updated
June 15, 2022
Record last verified: 2022-06