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

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

ClinicalTrials.gov Identifier: NCT04666272

Novartis Reference Number: CDRB436FCN01

Last Update: Mar 18, 2022

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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, 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.

Condition 
Melanoma
Phase 
Not Given
Overall status 
Recruiting
Start date 
Dec 31, 2020
Completion date 
Dec 31, 2026
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug
dabrafenib
There is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
Drug
trametinib
There is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled.

Eligibility Criteria

Inclusion Criteria:

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

≥18 years old of age at the time of informed consent and of Chinese descent
Signed written informed consent
Going to receive commercial dabrafenib and trametinib according to approved label

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
Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
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:

Known ocular melanoma
Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
Patient is not able to comply with the planned study procedures
Taken an investigational drug within 28 days prior to enrolment
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.

Study Locations

China
Novartis Investigative Site
Recruiting
Zhengzhou, 410100
Henan
China
Novartis Investigative Site
Recruiting
Changsha, 410013
Hunan
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Changchun, 130022
Jilin
China
Novartis Investigative Site
Recruiting
Hangzhou, 310022
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100036
-
China
Novartis Investigative Site
Recruiting
Wuhan, 430022
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]