Clinical trial NCT04666272: Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
Official title: Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Keywords: BRAF V600 mutation-positive melanoma
cutaneous or mucosal melanoma
China
dabrafenib
trametinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include Chinese patients with stage III BRAF V600 mutation positive melanoma treated with dabrafenib in combination with trametinib in a commercial setting.

Brief summary: This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.

Detailed description: The study will consist of a treatment phase and follow-up phase. The treatment period is 12 months. Discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. Patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (EOT)

Eligibility criteria: Inclusion Criteria:

Patient(s) must meet all of the following criteria to be eligible for inclusion:

1. ≥18 years old of age at the time of informed consent and of Chinese descent
2. Signed written informed consent
3. Going to receive commercial dabrafenib and trametinib according to approved label
4. Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:

   * for stage III cutaneous melanoma: as per American Joint Committee on Cancer (AJCC) 8th edition for melanoma
   * for stage III mucosal melanoma of the head and neck origin: as per AJCC 8th edition for mucosal melanoma of the head and neck
   * for stage III mucosal melanoma of anal canal, rectum and genital track origin: as per Chinese guidelines on the diagnosis and treatment of melanoma 2019 edition
5. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
6. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Exclusion Criteria:

Patient will be excluded from this study if he/she meets any of the following criteria:

1. Known ocular melanoma
2. Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
3. Patient is not able to comply with the planned study procedures
4. Taken an investigational drug within 28 days prior to enrolment
5. History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 36 months
measure: Safety of dabrafenib in combination with trametinib
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Novartis Investigative Site
state: Fujian
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Kunming
country: China
facility: Novartis Investigative Site
state: Yunnan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Wuhan
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: