Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice

Melanoma Clinical Trial

— ISABELLA  

Official title:

prospectIve Non-interventional Study of Clinical Outcomes And Biomarkers in Patients With Stage 0-IV mElanoma in reaL clinicaL prActice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402059
• Other study ID #: MELPRO-0921
• Status: Recruiting
• Start date: March 2, 2022
• Est. completion date: April 2025

Study information

• Verified date: June 2022
• Source: MelanomaPRO, Russia
• Contact: Igor V Samoylenko, MD, PhD
• Phone: +74993249024
• Email: i.samoylenko[@]ronc.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective non-interventional study of clinical outcomes and biomarkers in patients with stage 0-IV skin melanoma in real clinical practice

Description:

Most oncology experts now recognize that the most effective and safest treatment options should be considered for first-line therapy. Since the planned use of drugs, including dosing, treatment interruption and early discontinuation of treatment, in clinical practice may differ from the procedures used in clinical trials, post-marketing "real world" data are important to quantify the feasibility, acceptability, and practical considerations for prescribing targeted and immunotherapy. Therefore, for the clinical and scientific communities, it is of great interest to evaluate the choice of the patient and the method of treatment used in the daily practice of oncological centers in Russia. Moreover, the available data imply an association between PDl-1 expression and other biomarkers in tumors and the efficacy of drug therapy. The purpose of this study is to evaluate clinical outcomes in patients with stage 0-IV skin melanoma in real clinical practice in the context of different levels of PDl-1 expression in the tumor and other potential biomarkers. In addition, it is of interest to gain insight into the real-world data on the quality of life of melanoma patients treated for metastatic disease. It is well known, that the prognosis of patients with stage 0-IV melanoma is too heterogeneous, therefore, in this study, distinguish several cohorts will be organised.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1570
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Melanoma in Situ
• Melanoma Stage III
• Melanoma Stage IV
• Melanoma, Ocular
• Melanoma, Stage II
• Melanoma, Uveal

Intervention

Drug:
• surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin Russian Cancer Research Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
MelanomaPRO, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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