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

Sponsor
MelanomaPRO, Russia
Study ID
NCT05171374
Status
Unknown

Conditions

  • Melanoma
  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Observational stusy. No intervention is planned
  • Trametinib — DRUG
    Observational stusy. No intervention is planned

Study Details

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

Key Dates

Start date
Sep 30, 2021
Status verified
May 2022
Primary completion
Sep 30, 2023
Completion
Sep 30, 2024

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Adjuvant cohort
    Patients with resectable stage III melanoma, reciveng dabrafenib and trametinib in adjuvant settings
  • Arm: Metastatic cohort
    Patients with unresectable stage IIIC/D or stage IV melanoma, reciveng dabrafenib and trametinib in metastatic settings

Primary Outcome Measure

12-month RFS rate [ Time Frame: 12 months ]

Central Contacts

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