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

NCT ID: NCT05402059

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1570 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2025-04-30

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type: DRUG

Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

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.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type: DRUG

Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

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.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type: DRUG

Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

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.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type: DRUG

Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

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.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type: DRUG

Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

-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;

• 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;

• 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 ;

• 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;

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MelanomaPRO, Russia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

N.N. Blokhin Russian Cancer Research Center

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Igor V Samoylenko, MD, PhD

Role: CONTACT

i.samoylenko@ronc.ru

+74993249024

Kristina V Orlova, MD, PhD

Role: CONTACT

k.orlova@ronc.ru

+79629359242

Facility Contacts

Igor V Samoylenko, MD, PhD

Role: primary

i.samoylenko@ronc.ru

+74993249024

Kristina V Orlova, MD, PhD

Role: backup

k.orlova@ronc.ru

+79629359242

References

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.

Reference Type: DERIVED

PMID: 39469641 (View on PubMed)

Other Identifiers

MELPRO-0921

Identifier Type: -

Identifier Source: org_study_id