pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE

NCT05171374 | Unknown DMC

• 1 other identifier: CDRB436ARU01R / MELPRO-0721
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 15

Brief Summary

Prospective evaluation of clinical outcomes in patients with resectable or metastatic BRAF+ melanoma treated with dabrafenib and trametinib in real practice

Conditions

Melanoma Stage III; Melanoma Stage IV; Melanoma

Outcome Measures

Primary Outcomes (2)

• 12-month RFS rate

  The primary efficacy endpoint of the study is 12-month RFS rate, definded as the time form index date to the date of first documented relapse or death due to any cause

  12 months

• 12-month PFS rate

  The primary efficacy endpoint of the study is 12-month PFS rate, defined as the time from the index date to the date of the first documented progression by investigator judgement or death due to any cause. If a patient has not had an event, PFS will be censored at the date of the last tumor assessment

  12 months

Secondary Outcomes (14)

• To describe patient populations receiving dabrafenib and trametinib for stage III resectable melanoma with respect to demographics and clinical characteristics at index date (baseline).

  12 months

• To describe patient populations receiving dabrafenib and trametinib for stage IV metastatic melanoma with respect to demographics and clinical characteristics at index date (baseline)

  12 months

• Evaluate retrospectively the sequence of therapy prior to initiating treatment with Dabrafenib and Trametinib

  12 months

• Analyze prospectively treatment options following disease recurrence or progression on treatment with Dabrafenib and Trametinib

  12 months

• Analyze proportion (%) of patients receiving adjuvant therapy with Dabrafenib and Trametinib for melanoma stage IIIA/IIIB/IIIC/IIID

  12 months

Study Arms (2)

Adjuvant cohort

Patients with resectable stage III melanoma, reciveng dabrafenib and trametinib in adjuvant settings

Drug: Dabrafenib; Drug: Trametinib

Metastatic cohort

Patients with unresectable stage IIIC/D or stage IV melanoma, reciveng dabrafenib and trametinib in metastatic settings

Drug: Dabrafenib; Drug: Trametinib

Interventions

Dabrafenib DRUG

Observational stusy. No intervention is planned

Adjuvant cohort; Metastatic cohort

Trametinib DRUG

Observational stusy. No intervention is planned

Adjuvant cohort; Metastatic cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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. Study is going ro include patients receiving treatment of interest (dabrafenib and trametinib) for either adjuvant of metastatic setting of melanoma treatment.

You may qualify if:

• Male or female patients aged 18 years or older;
• Histologically confirmed stage III resectable or stage IV metastatic cutaneous melanoma with confirmed BRAF mutation, for whom the treating physician took the decision to initiate treatment with dabrafenib and trametinib before entering the study;
• Treatment with Dabrafenib and Trametinib was initiated no longer than 4 weeks (28 days) prior to written informed consent for this study;
• Performance status ≤ 2 by Eastern Cooperative Oncology Group (ECOG) scale;
• Patient is willing and able to participate in the study;
• Written informed consent for study participation.

You may not qualify if:

• Patients with a life expectancy of less than 3 months at the time of melanoma diagnosis, per the investigator's judgment.
• Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated or other non-interventional study \[NIS\] can be included as long as their standard of care is not altered by the study).
• Patients on active treatment for malignancies other than melanoma at the time of enrollment.

Sponsors & Collaborators

• MelanomaPRO, Russia: lead
• Novartis: collaborator

Study Sites (15)

Altai Regional Oncological Dispensary

Barnaul, Alatai, 656000, Russia

RECRUITING

Republican Clinical Oncology Center of Chuvashia

Cheboksary, Chuvashskaya Respublika, 428020, Russia

RECRUITING

Irkutsk Regional Oncological Dispensary

Irkutsk, Irkutsk Oblast, 664035, Russia

RECRUITING

Rostov Regional Oncological Dispensary

Rostov-on-Don, Rostov Oblast, 344006, Russia

RECRUITING

State Budget Health Institution of the Republic of Mordovia "Republican Oncological Dispensary"

Saransk, THE Republic of Mordovia, 430032, Russia

RECRUITING

Republican Clinical Oncological Dispensary named after Sergei Grigoryevich Primushko Ministry of Health of the Udmurt Republic

Izhevsk, The Udmurt Republic, 426009, Russia

RECRUITING

Ivanovo Regional Oncological Dispensary

Ivanovo, 153040, Russia

RECRUITING

KGBUZ "Krasnoyarsk regional clinical oncological dispensary named after A.I. A.I. Kryzhanovsky"

Krasnoyarsk, 660133, Russia

RECRUITING

N.N. Blokhin Russian Cancer Research Center

Moscow, 114578, Russia

RECRUITING

Moscow City Clinical Oncology Hospital No. 1

Moscow, 129090, Russia

RECRUITING

Omsk Regional Clinical Oncology Center

Omsk, 644013, Russia

RECRUITING

Perm Regional Oncological Dispensary

Perm, 614066, Russia

RECRUITING

Tambov Regional Oncological Clinical Dispensary

Tambov, 392000, Russia

RECRUITING

Sverdlovsk Regional Oncology Center

Yekaterinburg, 620043, Russia

NOT YET RECRUITING

GBUZ Yuzhno-Sakhalinsk oncologic dispensary

Yuzhno-Sakhalinsk, 693010, Russia

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Igor Samoylenko, MD

CONTACT

+74993249024; i.samoylenko@ronc.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 28, 2021
• Study Start: September 30, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (15)