C43
Conditions
Interventions
Group 1: The COMBI-r study aims to provide prospective data on the efficacy, safety and tolerability of the therapy in daily practice in a large population of patients with melanoma who receive the co
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age of 18 years 2. Diagnosis of non-resectable or metastatic melanoma with BRAF V600 mutation 3. Consent to participate in the present study after clarification by the physician 4. Treatment of melanoma with combination therapy from Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) according to prescription by the treating physician, initiated no longer than 12 weeks before admission into this study or immediately after inclusion in this study Should be initiated
Exclusion criteria
Exclusion criteria: 1. Previous treatment by an MEK inhibitor in monotherapy (including trametinib) or by any other BRAF / MEK inhibitor combinations than dabrafenib / trametinib 2. Dabrafenib / Trametinib combination treatment more than 12 weeks before consent to the study and start of the documentation 3. Current or upcoming participation in a clinical trial (including melanoma) 4. Ongoing or pending treatment of a tumor disease other than that of melanoma with the exception of keratoacanthoma, squamous cell carcinoma or basal cell carcinoma of the skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (progression-free survival), defined as the time from the start of treatment with Dabrafenib + Trametinib until the date of the first documented progression of the disease or death (any reason). PFS rates after 6, 12, 18 months follow-up. DCR (disease control rate), calculated as the proportion of treated patients who received a best clinical response from complete remission (CR) or partial remission (PR, partial remission), or a stabilization of the disease ( SD, stable disease) (eg 12, 24 months after initiation of therapy) OS (overall survival), defined as the time from the start of treatment with D + T to death (of any reason). OS rates, e.g. 12, 24 months after initiation of therapy. Multivariate analysis of clinical and biological markers for the identification of predictive factors for long-term use, defined as control of the disease (CR, PR or SD) 12, 24 or, as the case may be, 36 months after initiation of therapy DOT (duration of therapy, therapy duration), calculated from the start of treatment with D + T up to and including the last day of the last dose Percentage of patients who received other systemic therapies in the advanced, non-resectable or metastatic stage before initiation of therapy with D + T as well as the percentage of patients with other pre-treatment regimens (e.g., radiation, local therapies) Frequency (by type) and number of pretreatments. Frequency (by type) of treatment after therapy with D + T Percentage of treated patients with one or more dose reduction (s). Median duration of dose reductions, calculated as from the date of the modified dose until the date of return to the originally prescribed standard dose. Reasons for dose reduction. Calculated average dose (according to prescription). Changes in the course of the therapy with D + T of the scores on the quality of life, measured by the instruments: EQ5D, Facit-F Frequency and severity of adverse events. Percentage of patients with discontinuation due to an undesirable event ( | — |
Secondary
| Measure | Time frame |
|---|---|
| It is not specified for primary and secondary endpoints | — |
Countries
Germany
Contacts
Public ContactRalf Gutzmer
Hauttumorzentrum Hannover, Medizinische Hochschule Hannover
Outcome results
None listed