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

NCT04666272 | Active Not Recruiting

• 1 other identifier: CDRB436FCN01
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 8

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.

Conditions

Melanoma

Keywords

BRAF V600 mutation-positive melanoma; cutaneous or mucosal melanoma; China; dabrafenib; trametinib

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS)

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

  Up to 36 months

Secondary Outcomes (2)

• Overall survival (OS)

  Up to 36 months

• Safety of dabrafenib in combination with trametinib

  Up to 36 months

Study Arms (1)

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; Drug: trametinib

Interventions

dabrafenib DRUG

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.

dabrafenib in combination with trametinib as adjuvant treatment

trametinib DRUG

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.

dabrafenib in combination with trametinib as adjuvant treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Fuzhou, Fujian, 350014, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 410100, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location

Novartis Investigative Site

Changsha, Hunan, 410013, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210008, China

Location

Novartis Investigative Site

Kunming, Yunnan, 650106, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310022, China

Location

Novartis Investigative Site

Beijing, 100036, China

Location

MeSH Terms

Conditions

Melanoma

Interventions

dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 31, 2020
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): February 4, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)