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Sponsor: Novartis Pharmaceuticals
Conditions: Melanoma
Interventions: Dabrafenib, Trametinib, Placebos
Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia
This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk (Stage IIIa \[lymph node metastasis \>1 mm\], IIIb or IIIc) cutaneous melanoma were screened for eligibility. Approximately 852 patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc). Patients received either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or 2 matching placebos (one each for dabrafenib and trametinib) for 12 months or until disease recurrence, death, unacceptable toxicity, or withdrawal of consent. Patients were followed for disease recurrence and survival during and after the treatment period. The study did not permit crossover. Doses of study treatment could be modified and/or interrupted for management of toxicities associated with study treatment.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Key Inclusion Criteria: * At least 18 years of age * Completely resected histologically confirmed high-risk (Stage IIIa \[lymph node metastasis \> 1 mm\], IIIb or IIIc) cutaneous melanoma determined to be V600E/K mutation positive using the bioMerieux (bMX) THxID BRAF Assay by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma were eligible * Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before randomization * Recovered from definitive surgery (e.g., no uncontrolled wound infections or indwelling drains) * ECOG Performance Status of 0-1 * Had adequate hematologic, hepatic, renal and cardiac function. Key Exclusion Criteria: * Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases * Evidence of distant metastatic disease on Screening evaluation * Prior anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) including radiotherapy for melanoma. Prior surgery for melanoma was allowed * History of another malignancy including melanoma or a concurrent malignancy. Patients who previously had Stage III melanoma or any malignancy with confirmed activating RAS mutation at any time were not eligible. Exceptions to this include: * Patients with a history of any malignancy that had been disease-free for at least 5 years were eligible except those with confirmed activating RAS mutations * Patients with a history of completely resected non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) were eligible irrespective of the time since the resection * Patients with successfully treated in situ carcinoma were eligible * Patients presenting with multiple primary melanomas were eligible only if the lesions were concurrent. Patients who had concurrent multiple primary melanomas that were "distant" were eligible provided each lesion was considered local disease or resectable regional disease.
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- San Francisco, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Lake Worth, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Lutherville-Timonium, Maryland, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Capital Federal, Buenos Aires, Argentina
- Buenos Aires, Argentina
- Gateshead, New South Wales, Australia
- North Sydney, New South Wales, Australia
- Tweed Heads, New South Wales, Australia
- Westmead, New South Wales, Australia
- Greenslopes, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Box Hill, Victoria, Australia
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