Last Update: Jun 17, 2026 Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor ClinicalTrials.gov Identifier: [NCT06262919](https://clinicaltrials.gov/ct2/show/NCT06262919) Novartis Reference Number:CDRB436I1401 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture. In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice. Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set). Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set) The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product. Condition BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor Overall Status Recruiting Number of Participants110 Start Date Feb 09, 2024 Completion Date Dec 31, 2031 Gender All Age(s) 6 Years - 99 Years (Child, Adult, Older Adult) ## Interventions Drug ### Tafinlar/Mekinist There is no treatment allocation. Patients administered Tafinlar/Mekinist by prescription that have started before inclusion of the patient into the study will be enrolled. ## Eligibility Criteria Inclusion Criteria: 1\. Patients who have given written consent to cooperate in this surveillance 2\. For patients aged \\< 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment. 3\. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications Exclusion Criteria: 1\. Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance 2\. Patients with BRAF-mutation-positive malignant melanoma 3\. Patients with BRAF-mutation-positive non-small cell lung cancer 4\. Patients with BRAF-mutation-positive hairy cell leukemia Japan #### Novartis Investigative Site Recruiting Ohtsu,Shiga,5202192,Japan #### Novartis Investigative Site Recruiting Okayama,7008558,Japan #### Novartis Investigative Site Recruiting Kashiwa,Chiba,277-8577,Japan #### Novartis Investigative Site Recruiting Yoshida-gun,Fukui,910-1193,Japan #### Novartis Investigative Site Recruiting Sapporo,Hokkaido,0608543,Japan #### Novartis Investigative Site Recruiting Sapporo,Hokkaido,0650033,Japan #### Novartis Investigative Site Recruiting Yokohama,Kanagawa,236-0004,Japan #### Novartis Investigative Site Recruiting Sendai,Miyagi,9808574,Japan #### Novartis Investigative Site Recruiting Kawagoe,Saitama,3508550,Japan #### Novartis Investigative Site Recruiting Saitama,Saitama,330-8777,Japan #### Novartis Investigative Site Recruiting Hiroshima,7348551,Japan #### Novartis Investigative Site Recruiting Sunto Gun,Shizuoka,4118777,Japan #### Novartis Investigative Site Recruiting Bunkyo Ku,Tokyo,113-8655,Japan #### Novartis Investigative Site Recruiting Chuo Ku,Tokyo,104-8560,Japan #### Novartis Investigative Site Recruiting Chuo Ku,Tokyo,1040045,Japan #### Novartis Investigative Site Recruiting Shinjuku-ku,Tokyo,1608582,Japan #### Novartis Investigative Site Recruiting Kagoshima,8908520,Japan #### Novartis Investigative Site Recruiting Kochi,7818555,Japan #### Novartis Investigative Site Recruiting Kyoto,6068507,Japan #### Novartis Investigative Site Recruiting Shizuoka,4208660,Japan #### Novartis Investigative Site Recruiting Matsumoto,Nagano,3908621,Japan #### Novartis Investigative Site Recruiting Mito,Ibaraki,311-4145,Japan #### Novartis Investigative Site Recruiting Sagamihara,Kanagawa,252-0375,Japan #### Novartis Investigative Site Recruiting Minato-ku,Tokyo,105-8471,Japan #### Novartis Investigative Site Recruiting Nagoya,Aichi-ken,453-8511,Japan #### Novartis Investigative Site Recruiting Kurume,Fukuoka,830-0011,Japan #### Novartis Investigative Site Recruiting Fukuoka,Fukuoka,811-1395,Japan #### Novartis Investigative Site Recruiting Kobe,Hyōgo,6500047,Japan #### Novartis Investigative Site Recruiting Yokohama,Kanagawa,245-8575,Japan #### Novartis Investigative Site Recruiting Kyoto,Kyoto,602-8566,Japan #### Novartis Investigative Site Recruiting Fukuyama,Hiroshima,721-8511,Japan #### Novartis Investigative Site Recruiting Yufu,Oita Prefecture,8795593,Japan #### Novartis Investigative Site Recruiting Okayama,Okayama-ken,7011192,Japan #### Novartis Investigative Site Recruiting Osaka,Osaka,5340021,Japan #### Novartis Investigative Site Recruiting Takatsuki,Osaka,5698686,Japan #### Novartis Investigative Site Recruiting Bunkyo-ku,Tokyo,1138519,Japan #### Novartis Investigative Site Recruiting Setagaya-ku,Tokyo,1578535,Japan #### Novartis Investigative Site Recruiting Wakayama,Wakayama,641-8510,Japan #### Novartis Investigative Site Recruiting Fukuoka,8128582,Japan ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +81337978748](tel:+81337978748) Email: