Malignant melanoma of skin
Conditions
Interventions
Clinical trial phase III for the treatment of malignant melanoma of skin. The study will randomize approximately 852 subjects. Brazil will randomize 20 subjects.
Experimental arm: 426 subjects will re
Drug
D26.660
Sponsors
GlaxoSmithKline Brasil
GlaxoSmithKline Brasil
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Completely resected histologically confirmed high-risk, stage IIIa, LN metastasis more than 1 mm, IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible; Surgically rendered free of disease no more than 12 weeks before randomization; Recovered from definitive surgery, e.g. no uncontrolled wound infections or indwelling drains; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; Adequate hematologic, hepatic, renal and cardiac function.
Exclusion criteria
Exclusion criteria: Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases; Evidence of distant metastatic disease; Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed; History of another malignancy or concurrent malignancy including prior malignant melanoma; Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for more than 5 years; History or current evidence of cardiovascular risk; History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint of this study is relapse free survival (RFS) which is defined as the time from randomization to disease recurrence or death from any cause. Recurrence of or death from the same cancer and all deaths from other causes are events. Treatment emergent malignancies (excluding second melanomas) will not be considered as events, and loss to follow-up is censored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last contact. ;Distant metastasis-free survival (DMFS), defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurs first. Patients alive and without distant metastasis are censored at the date of last assessment. ;Freedom from relapse (FFR), defined as interval from randomization to local or distant recurrence or new melanoma primary, with censoring of patients dying fromcauses other than melanoma or treatment-related toxicity at the date of death. Incidence of new melanoma will not be considered as an event. Patients alive without recurrence or with second primary cancers will be censored at the date of last assessment. ;The secondary objectives of the study include characterizing the safety of dabrafenib and trametinib combination therapy. As a consequence, clinical assessments including vital signs and physical examinations, 12-lead ECG, ECHO, eye exams, chemistry and hematology laboratory values, and AEs will be monitored and evaluated. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactServiço de Atendimento ao Cliente SAC
GlaxoSmithKline Brasil
Outcome results
None listed