Clinical Trials Logo
  1. Home
  2. Malignant Melanoma
  3. NCT04547946

Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)

Malignant Melanoma Clinical Trial

Official title:
Impact of Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib) on Patients Quality of Life (QoL) and Clinical Outcomes in Portuguese Real World Setting

Clinical Trial Summary

The primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire. The secondary study objectives were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.

Clinical Trial Description

The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience. Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with dabrafenib and trametinib had already been made. All patients that complied with the inclusion criteria and that started treatment with dabrafenib+ trametinib during the recruitment period were considered to participate in the study, at investigator discretion. Health related quality of life had to be assessed by FACT-M and EQ-5D-3L questionnaires after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04547946
Study type Observational
Source Novartis
Contact
Status Completed
Phase
Start date October 15, 2021
Completion date June 7, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT03653819 - High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs N/A
Recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Completed NCT02935790 - Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab Phase 1
Recruiting NCT05478876 - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract N/A
Completed NCT01211262 - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma Phase 1
Recruiting NCT03649529 - Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy Early Phase 1
Completed NCT03278665 - 4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy Phase 1/Phase 2
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Completed NCT01455259 - Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors Phase 1/Phase 2
Completed NCT00978913 - Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00350597 - GM-CSF as Adjuvant Therapy of Melanoma Phase 2
Completed NCT00336986 - Efficacy Study of IL-21 to Treat Metastatic Melanoma Phase 2
Completed NCT02523313 - Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED Phase 2
Completed NCT03545334 - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study N/A
Completed NCT04253574 - Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
Completed NCT00179608 - Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy Phase 1
Terminated NCT00104884 - FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma Phase 2