MelanomaISABELLANCT05402059
Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice
An observational study of Melanoma and Melanoma (Skin), run by MelanomaPRO, Russia at 1 site in Russia.
Trial summary
Prospective non-interventional study of clinical outcomes and biomarkers in patients with stage 0-IV skin melanoma in real clinical practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Melanoma (Skin), Melanoma, Uveal
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- Type of treatment
- Injection or infusion
- How many people
- 1,570 participants
- Where
- 1 siteRussia
- Study dates
- 2 Mar 2022to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Show all 13Show fewer
- -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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin Russian Cancer Research Center
Moscow, 115522
Igor V Samoylenko, MD, PhD, +74993249024, i.samoylenko@ronc.ru
Kristina V Orlova, MD, PhD, +79629359242, k.orlova@ronc.ru
About this study
Official title: prospectIve Non-interventional Study of 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 skin melanoma in real clinical practice
Read the 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
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesDrug
Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines | |
| 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. Receives: Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines | |
| 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. Receives: Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines | |
| 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. Receives: Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines | |
| 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. Receives: Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start2 Mar 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MelanomaPRO, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402059
- Sponsor's protocol ID
- MELPRO-0921
- Acronym
- ISABELLA
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39469641
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- prospectIve Non-interventional Study of Clinical Outcomes And Biomarkers in Patients With Stage 0-IV mElanoma in reaL clinicaL prActice
- ClinicalTrials.gov ID
- NCT05402059
- Acronym / sponsor ID
- ISABELLA / MELPRO-0921
- Conditions
- Melanoma, Melanoma (Skin), Melanoma, Uveal, Melanoma Stage IV, Melanoma Stage III, Melanoma, Stage II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,570 participants (estimated)
- Lead sponsor
- MelanomaPRO, RussiaUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesStudy 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 | – | Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesStudy 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 | – | Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesStudy 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 | – | Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesStudy 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 | – | Drug: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesAny kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice | Drug | Cohort A, Cohort A1, Cohort B, Cohort C, Cohort D |
Primary outcome
12-month relapse-free survival
Time frame: 12 months
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-month progression free survival
Time frame: 12 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 39469641Samoylenko 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Melanoma (Skin), run by MelanomaPRO, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor V Samoylenko, MD, PhD (+74993249024, i.samoylenko@ronc.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month relapse-free survival (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.