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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04666272

Collaborator

(none)

150

Enrollment

Locations

Anticipated Duration (Months)

21.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: dabrafenib Drug: trametinib

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 31, 2020

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
dabrafenib in combination with trametinib as adjuvant treatment Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used.	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.

Arm

Intervention/Treatment

dabrafenib in combination with trametinib as adjuvant treatment

Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used.

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.

Outcome Measures

Primary Outcome Measures

Relapse-free survival (RFS) [Up to 36 months]
Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.

Secondary Outcome Measures

Overall survival (OS) [Up to 36 months]
Overall survival (OS) defined as the time from start of treatment to death due to any cause
Safety of dabrafenib in combination with trametinib [Up to 36 months]
Adverse events (AEs) and serious adverse events (SAEs) will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Zhengzhou	Henan	China	410100
2	Novartis Investigative Site	Changsha	Hunan	China	410013
3	Novartis Investigative Site	Nanjing	Jiangsu	China	210008
4	Novartis Investigative Site	Changchun	Jilin	China	130022
5	Novartis Investigative Site	Hangzhou	Zhejiang	China	310022
6	Novartis Investigative Site	Beijing		China	100036
7	Novartis Investigative Site	Wuhan		China	430022